FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredient (In Each Rectal Suppository)
Acetaminophen 120 mg
Pain reliever/fever reducer
- •reduces fever
- •relieves minor aches, pains, and headache
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
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
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.
- •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
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)
- •store at 20-25°C (68-77°F) or in a cool place
- •tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
hydrogenated vegetable oil
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Compare to FeverAll® active ingredient
Acetaminophen Suppositories USP, 120 mg
Pain Reliever/Fever Reducer
Ages 3-6 years
See New Warning
12 RECTAL SUPPOSITORIES, 120 mg EACH
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