FDA Label for Acetaminophen For Children
View Indications, Usage & Precautions
Acetaminophen For Children Product Label
The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Rectal Suppository)
Acetaminophen 120 mg
Purposes
Pain reliever/fever reducer
Uses
temporarily
• reduces fever• relieves minor aches, pains, and headache
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• skin reddening• blisters• rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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) |
Other Information
• 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.
Inactive Ingredient
hydrogenated vegetable oil
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Compare to FeverAll® active ingredient
For Children
Acetaminophen Suppositories USP, 120 mg
Pain Reliever/Fever Reducer
Ages 3-6 years
See New Warning
12 RECTAL SUPPOSITORIES, 120 mg EACH
* Please review the disclaimer below.