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ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER - acetaminophen suppository 
Perrigo New York Inc

Perrigo Acetaminophen Suppositories USP, 650 mg Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen 650 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

  • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • an adult takes 3 or more alcoholic drinks every day while using this product

For rectal use only

Do not use

  • in children under 12 years
  • 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

  • you have liver disease
  • you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • fever lasts more than 3 days (72 hours), or recurs.
  • pain gets worse or lasts more than 10 days.
  • new symptoms occur.
  • redness or swelling is present in the painful area.

These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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

  • do not use more than directed
  • remove wrapper
  • carefully insert suppository well up into the rectum
  • adults and children 12 years and older:
  • 1 suppository every 4 to 6 hours while symptoms last
  • do not exceed 6 suppositories in any 24 hour period
  • children under 12 years: ask a doctor

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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Acetaminophen Suppositories USP, 650 mg

Pain Reliever/Fever Reducer

See New Warnings Information

Read and Keep Carton for New Liver Warning

650 mg Each

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Acetaminophen Suppositories USP, 650 mg Carton Image #1

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Acetaminophen Suppositories USP, 650 mg Carton Image #2


ACETAMINOPHEN  PAIN RELIEVER FEVER REDUCER
acetaminophen  suppository
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 45802-730
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 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 45802-730-32 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 5 SUPPOSITORY In 1 BLISTER PACK This package is contained within the CARTON (45802-730-32)
2 45802-730-30 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK
2 6 SUPPOSITORY In 1 BLISTER PACK This package is contained within the CARTON (45802-730-30)
3 45802-730-33 20 BLISTER PACK In 1 CARTON contains a BLISTER PACK
3 5 SUPPOSITORY In 1 BLISTER PACK This package is contained within the CARTON (45802-730-33)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070608 10/28/2010

Labeler - Perrigo New York Inc (078846912)
Revised: 10/2010Perrigo New York Inc