PAIN RELIEVER FEVER REDUCER CHILDRENS- acetaminophen suppository

pain reliever fever reducer by

Drug Labeling and Warnings

pain reliever fever reducer by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

• the child has liver disease
• the 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 ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to FeverALL® active ingredient

for children

Pain Reliever / Fever Reducer

ACETAMINOPHEN SUPPOSITORIES 120 mg

PAIN RELIEVER / FEVER REDUCER

AGES 3-6 YEARS

12 RECTAL SUPPOSITORIES, 120 mg EACH

NOT ACTUAL SIZE

INGREDIENTS AND APPEARANCE

PAIN RELIEVER FEVER REDUCER  CHILDRENS
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0579
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	120 mg

Inactive Ingredients
Ingredient Name	Strength
COTTONSEED OIL (UNII: H3E878020N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0579-53	12 in 1 CARTON	03/11/2011
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA070607	02/19/2010

Labeler - Walgreen Company (008965063)