ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER- acetaminophen suppository 
Physicians Total Care, Inc.

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Active ingredient (in each rectal suppository)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

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

Other information

Inactive ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

PRINCIPAL DISPLAY PANEL

Acetaminophen Suppositories USP, 650 mg

NDC 54868-4991-0

image of package label

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 AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-4991-02 in 1 CARTON
16 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/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 4/2011
Document Id: 3ea83636-fc0a-4085-8693-f0f1947b5454
Set id: cddc841a-ab37-4480-a9d1-4764cba3ec80
Version: 1
Effective Time: 20110413
 
Physicians Total Care, Inc.