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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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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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