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Name:Acetaminophenpain Reliever Fever Reducer
Manufacturer:Perrigo New York Inc
Category:Over-the-counter (OTC) Marketed Drugs


Perrigo Acetaminophen Suppositories USP, 650 mg Drug Facts

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

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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

Principal Display Panel

Acetaminophen Suppositories USP, 650 mg

Pain Reliever/Fever Reducer

See New Warnings Information

Read and Keep Carton for New Liver Warning

650 mg Each

Acetaminophen Suppositories USP, 650 mg Carton Image #1

Acetaminophen Suppositories USP, 650 mg Carton Image #1

Acetaminophen Suppositories USP, 650 mg Carton Image #2

Acetaminophen Suppositories USP, 650 mg Carton Image #2


ACETAMINOPHEN  PAIN RELIEVER FEVER REDUCER
acetaminophen suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-730
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-730-32 10 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 5 SUPPOSITORY ( SUPPOSITORY) in 1 BLISTER PACK This package is contained within the CARTON (45802-730-32)
2 NDC:45802-730-30 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 6 SUPPOSITORY ( SUPPOSITORY) in 1 BLISTER PACK This package is contained within the CARTON (45802-730-30)
3 NDC:45802-730-33 20 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
3 5 SUPPOSITORY ( 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: 10/2010 Perrigo New York Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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