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ACETAMINOPHEN FOR CHILDREN - acetaminophen suppository 
Perrigo New York Inc

Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen 120 mg

Purpose

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 ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

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Compare to FeverAll® active ingredient

For Children

Acetaminophen Suppositories USP, 120 mg

Pain Reliever/Fever Reducer

See New Warnings Information

Read and Keep Carton for New Liver Warning

120 mg Each

Acetaminophen Suppositories USP, 120 mg Carton Image 1

Acetaminophen Suppositories USP, 120 mg Carton Image 1

Acetaminophen Suppositories USP, 120 mg Carton Image 2

Acetaminophen Suppositories USP, 120 mg Carton Image 2


ACETAMINOPHEN  FOR CHILDREN
acetaminophen  suppository
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 45802-732
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 45802-732-33 20 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 5 SUPPOSITORY In 1 BLISTER PACK This package is contained within the CARTON (45802-732-33)
2 45802-732-30 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK
2 6 SUPPOSITORY In 1 BLISTER PACK This package is contained within the CARTON (45802-732-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070607 12/14/2010

Labeler - Perrigo New York Inc (078846912)
Revised: 09/2011Perrigo New York Inc