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ACETAMINOPHEN pain reliever/fever reducer

Medically reviewed on April 13, 2018

Dosage form: suppository
Ingredients: ACETAMINOPHEN 650mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-4991

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

NDC 54868-4991-0

Pain Reliever/Fever Reducer

See New Warnings Information

Read and Keep Carton for New Liver Warning

650 mg Each

ACETAMINOPHEN  PAIN RELIEVER/FEVER REDUCER
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-4991(NDC:45802-730)
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL 
Packaging
#Item CodePackage Description
1NDC:54868-4991-02 BLISTER PACK (BLISTER PACK) in 1 CARTON
16 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07060802/03/2004
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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