Your browser does not support JavaScript! FEVER REDUCING CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [CVS PHARMACY]
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RxNorm Names

FEVER REDUCING CHILDRENS (acetaminophen) suppository
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each rectal suppository)

Acetaminophen 120 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 your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

For rectal use only

Do not use

  • 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

  • your child has liver disease
  • your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • fever lasts more than 3 days (72 hours), or recurs.
  • pain lasts more than 5 days or gets worse.
  • new symptoms occur.
  • redness or swelling is present in the painful area.

These may be signs of a serious condition.

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

  • this product does not contain directions or warnings for adult use
  • do not use more than directed
  • remove wrapper
  • carefully insert suppository well up into the rectum
Dosing Chart
AgeDose
under 3 yearsDo not use unless directed by a doctor
3 to 6 yearsUse a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

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

Compare to the active ingredient in FeverAll®

See New Warnings Information

Children's

FEVER REDUCING SUPPOSITORIES

ACETAMINOPHEN SUPPOSITORIES 120 mg

Pain reliever / Fever reducer

Read and Keep Carton for New Liver Warning

120 mg EACH

Fever Reducing Suppositories Carton Image 1

Fever Reducing Suppositories Carton Image 1

Fever Reducing Suppositories Carton Image 2

Fever Reducing Suppositories Carton Image 2

FEVER REDUCING  CHILDRENS
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-579
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN120 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-579-532 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07060701/21/2010
Labeler - CVS Pharmacy (062312574)

Revised: 9/2011
 
CVS Pharmacy

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