Each Donnatal Extentabs® tablet contains:

Phenobarbital, USP (3/4 gr.) ................................ 48.6 mg
Hyoscyamine Sulfate, USP ................................... 0.3111 mg
Atropine Sulfate, USP ............................................ 0.0582 mg
Scopolamine Hydrobromide, USP ...................... 0.0195 mg

Each Donnatal Extentabs® tablet contains the equivalent of three Donnatal® tablets. Extentabs® are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.

In addition, each tablet contains the following inactive ingredients: Anhydrous Lactose, Calcium Sulfate Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, and Stearic Acid. Film Coating and Polishing Solution contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.

Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the following indications as "possibly" effective:

For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

The dosage of Donnatal Extentabs® should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The usual dose is one tablet every twelve (12) hours. If indicated, one tablet every eight (8) hours may be given.

Donnatal Extentabs® Tablets are supplied as: film coated green, round, compressed tablets printed "P421" in black ink.

• Bottles of 100 tablets
• Bottles of 500 tablets

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure.

Also available: Donnatal® Tablets in bottles of 100 and 1000 tablets and Donnatal® Elixir in 4 fl oz bottles and 1 pint bottles.

PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. FDA Rev date: n/a

Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness: insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.

Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

No information provided.

In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

Donnatal Extentabs® may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

Phenobarbital may decrease the effect of anticoagulants and necessitate larger doses of the anticoagulant for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.

Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.

Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.

Theoretically, with overdosage, a curare-like action may occur.

Carcinogenesis, mutagenesis: Long-term studies in animals have not been performed to evaluate c arcinogenic potential.

Pregnancy Category C: Animal reproduction studies have not been conducted with Donnatal Extentabs®. It is not known whether Donnatal Extentabs® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal Extentabs® should be given to a pregnant woman only if clearly needed.

Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal Extentabs® is administered to a nursing mother.

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be added.

Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.

Donnatal Extentabs® is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated,in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.

ACTIONS: This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

BELLADONNA ALKALOIDS/PHENOBARBITAL - ORAL

(bell-a-DON-a al-KA-loyd/fee-noe-BAR-bi-tal)

USES: This medication is used along with other medications to treat certain intestine problems (irritable bowel syndrome, enterocolitis). This medication contains several medications, phenobarbital and belladonna alkaloids (hyoscyamine, atropine, scopolamine). This medication belongs to a class of drugs known as anticholinergic/antispasmodic drugs. It works by decreasing intestine cramping and calming the nerves.

HOW TO USE: Take this medication by mouth, exactly as prescribed by your doctor. Follow your doctor's instructions carefully on taking this drug with or without food. If you are taking the extended-release tablets, take them usually every 8 to 12 hours. If you are taking the regular-release tablets or elixir, take them usually 3 to 4 times daily. Children may be prescribed the elixir every 4 to 6 hours.

If you are taking the extended-release tablets, swallow the medication whole. Do not crush or chew the medication. Doing so can destroy the long action of the drug and may increase side effects.

Dosage is based on your medical condition and response to treatment. Dosage for children is also based on body weight. Your doctor may adjust your dosage to control symptoms and decrease side effects.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in higher doses. In such cases, withdrawal reactions (e.g., anxiousness, muscle twitching, shakiness, dizziness, worsening weakness, nausea, vomiting) may occur if you suddenly stop this drug. Withdrawal from the phenobarbital can be severe and include seizures and (rarely) death. To prevent withdrawal reactions when stopping extended, high-dose, regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed. Tell your doctor if your condition persists or worsens at any time while taking this medication.

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, dry mouth, dry eyes, constipation, or fast heartbeat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on hard candy or ice chips, chew gum, drink water, or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, and drink plenty of water. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular heartbeat, weakness, headache, mental/mood changes (e.g., nervousness, confusion, agitation, excitement), loss of taste, nausea, vomiting, decreased sweating, reduced tolerance of heat/strenuous exercise, problems starting the flow of urine, decreased sexual ability/interest.

For more details about heat tolerance, see Precautions section.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking belladonna alkaloids with phenobarbital, tell your doctor or pharmacist if you are allergic to hyoscyamine, atropine, scopolamine, or phenobarbital; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma, urine blockage due to enlarged prostate, blockage or narrowing in the stomach/intestines, severe slowing or stoppage of the intestines (e.g., intestinal atony, paralytic ileus), any condition that causes immobility (e.g., being bedridden), severe bleeding, a certain severe form of intestinal disease (ulcerative colitis), a certain muscle disease (myasthenia gravis), severe bleeding with fainting, hiatal hernia with heartburn, a certain blood/liver problem (acute intermittent porphyria), restlessness or excitement due to past use of phenobarbital.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, heart disease (e.g., angina, heart rhythm problems, previous heart attack, chronic heart failure), high blood pressure, sleep apnea, nerve problems causing slowing of the intestines (autonomic neuropathy), mental/mood disorders (e.g., toxic psychosis, depression), stomach ulcer.

This drug may make you dizzy or drowsy or cause blurred vision. Use caution while driving, using machinery, or doing any activity that requires alertness and clear vision. Avoid alcoholic beverages because they may increase the risk of these side effects.

When this medication is taken in hot weather, a certain serious condition (heat prostration) may occur due to decreased sweating. Drink plenty of fluids and dress lightly while in hot weather or when exercising. Check carefully for signs of decreased sweating. If this occurs, promptly seek cooler or air-conditioned shelter and/or stop exercising. Seek immediate medical attention if your body temperature is above normal or if you have mental/mood changes, headache, or dizziness.

If you wear contact lenses and have dry eyes, you may need to use appropriate lubricating drops. Consult your doctor or pharmacist.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness and urination problems.

This medication is not recommended for use during pregnancy. Consult your doctor for details. Birth control pills may not be effective if taken with this medication (see also Drug Interactions section). Discuss reliable forms of birth control with your doctor. If you become pregnant while taking this medication, tell your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast milk production may also be decreased by this medication. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: etravirine, sodium oxybate, pramlintide, potassium tablets/capsules, delavirdine, darunavir, voriconazole.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting belladonna alkaloids with phenobarbital.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: warfarin, estrogens, corticosteroids (e.g., prednisone, dexamethasone), quinidine, felodipine, metronidazole, doxycycline, certain antifungal medications (griseofulvin, posaconazole), phenytoin, valproic acid, cyclosporine, certain cancer drugs (sunitinib, erlotinib, dasatinib, lapatinib, irinotecan), telithromycin, certain beta blockers (acebutolol, betaxolol, carteolol, metoprolol, propranolol), exemestane, theophylline, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

This medication can speed up the removal of many other drugs from your body by affecting certain liver enzymes. This can affect how well these other drugs work. Tell your doctor or pharmacist of all other drugs you take.

Before using this medication, tell your doctor or pharmacist if you use any other prescription and nonprescription products that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., methocarbamol), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that have similar side effects to this medication (e.g., drowsiness, dry eyes, dry mouth, constipation, urination problems). Ask your pharmacist about using those products safely.

This medication may decrease the effectiveness of combination-type birth control pills or patches/rings. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details. (See also Precautions section.)

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: headache, restlessness, unusual behavior, excitability, nausea, vomiting, blurred vision, widened pupils, hot and dry skin, dizziness, dry mouth, difficulty swallowing.

NOTES: Do not share this medication with others.

Keep all medical appointments so that your progress can be monitored or you can be checked for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2008 Copyright(c) 2008 First DataBank, Inc.