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Feverall Adults

Dosage form: suppository
Ingredients: Acetaminophen 650mg
Labeler: Taro Pharmaceuticals U.S.A. Inc.
NDC Code: 51672-2117

Feverall®
Adults

Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 650 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

  • 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

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

  • 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. 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
  • 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

ADULTS'
ages 12 years & older

FeverAll®
ACETAMINOPHEN
SUPPOSITORIES

Pain Reliever/Fever Reducer

NOT FOR RETAIL SALE
NDC 51672-2117-4

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

50
Rectal
Suppositories

650
mg
each

FEVERALL   ADULTS
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2117
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg
Inactive Ingredients
Ingredient NameStrength
glyceryl monostearate 
hydrogenated palm kernel oil 
PEG-100 stearate 
polysorbate 80 
Packaging
#Item CodePackage Description
1NDC:51672-2117-450 BLISTER PACK in 1 CARTON
1NDC:51672-2117-01 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(51672-2117)

 
Taro Pharmaceuticals U.S.A. Inc.

Medically reviewed on May 21, 2018

Further information

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

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