Acephen

What is Acephen and how is it used?

Acephen is a prescription medicine used to treat the symptoms of Fever and Pain (Antipyretic/Analgesic). Acephen may be used alone or with other medications.

Acephen belongs to a class of drugs called Analgesics, Other.

It is not known if Acephen is safe and effective in children younger than 3 months of age.

What are the possible side effects of Acephen?

Acephen may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• skin redness,
• rash that spreads and causes blistering and peeling,
• nausea,
• upper stomach pain,
• loss of appetite,
• itching,
• dark urine,
• clay-colored stools, and
• yellowing of the skin or eyes (jaundice)

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Acephen include:

• none indicated

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Acephen. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Active Ingredient (in each rectal suppository)

Acetaminophen 650 mg

Inactive Ingredients

glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate

INDICATIONS

Purpose

Pain reliever/fever reducer

Uses

temporarily

• reduces fever
• relieves minor aches, pains, and headache

DOSAGE AND ADMINISTRATION

Directions

• do not use more than directed
• remove foil wrapper
• carefully insert suppository well up into rectum
• adults and children 12 years and older
  • 1 suppository every 4 to 6 hours while symptoms persist
  • do not exceed 6 doses in any 24-hour period
• children under 12 years : do not use

HOW SUPPLIED

Dosage Forms And Strengths

NDC 0713-0165-01

Storage

• store at 15°-30°C (59°-86°F)

G&W Laboratories, Inc. Revised: Jan 2012

SIDE EFFECTS

No information provided.

DRUG INTERACTIONS

No information provided.

WARNINGS

For rectal use only

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if

• an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• an adult takes 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

• in children under 12 years
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• you have liver disease
• you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• fever lasts more than 3 days (72 hours), or recurs
• pain gets worse or lasts more than 10 days
• new symptoms occur
• redness or swelling is present in the painful area

These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and
for children even if you do not notice any signs or symptoms If swallowed, get medical help or contact a poison control center right away.

PRECAUTIONS

See WARNINGS above.

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

CLINICAL PHARMACOLOGY

No information provided.

PATIENT INFORMATION

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