Each tablet contains: Chlorpheniramine Maleate 4 mg.

May also contain: D&C Yellow #10, Lactose, Magnesium Stearate, Microcrystalline Cellulose and Pregelatinized Starch.

Last updated on RxList: 12/8/2004

Provides effective, temporary relief of sneezing, watery and itchy eyes, and runny nose due to hay fever and other upper respiratory allergies.

Adults and children 12 years of age and older: One tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours or as directed by a physician.

Children 6 through 11 years: One half the adult dose (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours.

Children under 6 years of age: Consult a physician.

Chlorpheniramine Maleate Tablets are supplied as follows:

4 mg - Round, convex, yellow tablets bisected and imprinted with 44 over 194 on one side.

NDC 51079-163-20- Unit dose blister packages of 100 (10 strips of 10 tablets each).

Storage: Store at controlled room temperature 15° to 30° C (59° to 86° F).
Protect product from excessive moisture.

Last updated on RxList: 12/8/2004

>10%:

Central nervous system: Slight to moderate drowsiness
Respiratory: Thickening of bronchial secretions

1% to 10%:

Central nervous system: Headache, excitability, fatigue, nervousness, dizziness
Gastrointestinal: Nausea, xerostomia, diarrhea, abdominal pain, appetite increase, weight gain
Genitourinary: Urinary retention
Neuromuscular & skeletal: Arthralgia, weakness
Ocular: Diplopia
Renal: Polyuria
Respiratory: Pharyngitis

Substrate of CYP2D6 (minor), 3A4 (major); Inhibits CYP2D6 (weak).

Increased toxicity (CNS depression): CNS depressants, MAO inhibitors, tricyclic antidepressants, phenothiazines.

CYP3A4 inhibitors: May increase the levels/effects of chlorpheniramine. Example inhibitors include azole antifungals, ciprofloxacin, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, and verapamil.

Last updated on RxList: 12/8/2004

May cause excitability especially in children. Do not take this product unless directed by a physician, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages, and do not take this product if you are taking sedatives or tranquilizers without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

No information provided.

Last updated on RxList: 12/8/2004

No information provided.

Hypersensitivity to chlorpheniramine maleate or any component of the formulation; narrow-angle glaucoma; bladder neck obstruction; symptomatic prostate hypertrophy; during acute asthmatic attacks; stenosing peptic ulcer; pyloroduodenal obstruction. Avoid use in premature and term newborns due to possible association with SIDS.

Last updated on RxList: 12/8/2004

Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract.

Last updated on RxList: 12/8/2004

See WARNINGS section.

Last updated on RxList: 12/8/2004