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Feverall Childrens

Medically reviewed on May 21, 2018

Dosage form: suppository
Ingredients: Acetaminophen 120mg
Labeler: Taro Pharmaceuticals U.S.A. Inc.
NDC Code: 51672-2115

Feverall®
Children's

Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 120 mg

Purposes

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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
  • the child has liver disease.
  • the 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. 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 years Do not use unless directed by a doctor
 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Other information
  • store at 2°-27°C (35°-80°F)
  • do not use if imprinted suppository wrapper is opened or damaged

Inactive ingredients

glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

Questions?

call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 50 Suppository Carton

NOT FOR RETAIL SALE
NDC 51672-2115-4

CHILDREN'S
ages 3-6 years

FeverAll®
ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

50
Rectal
Suppositories

120
mg
each

FEVERALL   CHILDRENS
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2115
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen120 mg
Inactive Ingredients
Ingredient NameStrength
glyceryl monostearate 
hydrogenated palm kernel oil 
PEG-100 stearate 
polysorbate 80 
Packaging
#Item CodePackage Description
1NDC:51672-2115-26 BLISTER PACK in 1 CARTON
1NDC:51672-2115-01 SUPPOSITORY in 1 BLISTER PACK
2NDC:51672-2115-450 BLISTER PACK in 1 CARTON
2NDC:51672-2115-01 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01833712/12/2013
Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370)
Establishment
NameAddressID/FEIOperations
G&W NC Laboratories, Inc.079419931MANUFACTURE(51672-2115)

 
Taro Pharmaceuticals U.S.A. Inc.

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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