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ACETAMINOPHEN SUPPOSITORIES USP, 120MG, 12CT - 120 mg/1 SUPPOSITORY
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ACETAMINOPHEN SUPPOSITORIES USP, 120MG, 12CT

Generic: Acetaminophen

ACETAMINOPHEN SUPPOSITORIES USP, 120MG, 12CT

NDC:45802-0732-30
Manufacturer:Padagis Israel Pharmaceuticals Ltd
Strength:120 mg/1
Dosage Form:SUPPOSITORY
Route:RECTAL

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Drug Information

Identification

Generic Name

Acetaminophen

Brand Name

acetaminophen for children

Labeler / Distributor

Padagis Israel Pharmaceuticals Ltd

Product Type

HUMAN OTC DRUG

Administration

Dosage Form

SUPPOSITORY

Route of Administration

RECTAL

FDA Application Number

ANDA070607

Active Ingredients

IngredientStrength
ACETAMINOPHEN120 mg/1

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

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

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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. For rectal use only Do not use • 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 • your child has liver disease • your child is taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs. • pain lasts more than 5 days or gets worse. • new symptoms occur. • redness or swelling is present in the painful area. These may be signs of a serious condition. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions • this product does not contain directions or warnings for adult use • do not use more than directed • remove wrapper • carefully insert suppository well up into the rectum Dosing Chart Age Dose under 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.