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acetaminophen for children by Perrigo New York Inc

Dosage form: suppository
Ingredients: ACETAMINOPHEN 120mg
Labeler: Perrigo New York Inc
NDC Code: 45802-732

Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts

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

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 a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Other information
tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
store at 20°-25°C (68°-77°F) or in a cool place

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

Read and Keep Carton for New Liver Warning

100 Rectal Suppositories, 120 mg Each

ACETAMINOPHEN  FOR CHILDREN
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-732
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN120 mg
Packaging
#Item CodePackage Description
1NDC:45802-732-33100 BLISTER PACK in 1 CARTON
11 SUPPOSITORY in 1 BLISTER PACK
2NDC:45802-732-3012 BLISTER PACK in 1 CARTON
21 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07060712/14/2010
Labeler - Perrigo New York Inc (078846912)

Revised: 08/2014
 
Perrigo New York Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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