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FeverALL Adults

Dosage form: suppository
Ingredients: ACETAMINOPHEN 650mg
Labeler: Actavis Mid Atlantic LLC
NDC Code: 0472-1203

FeverAll ® (Acetaminophen Suppositories) ADULTS

ACTIVE INGREDIENT

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 everyday 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.

PREGNANCY OR BREAST FEEDING

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 2º-27ºC (35º-80ºF)
  • do not use if imprinted suppository wrapper is opened or damaged

INACTIVE INGREDIENTS

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

QUESTIONS

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Adults’

Ages 12 Years And Older

NOT FOR RETAIL SALE

NDC 0472-1203-50

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

50 Rectal Suppositories

650 mg each

50 RECTAL SUPPOSITORIES CARTON LABEL

FEVERALL ADULTS 
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1203
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
POLYSORBATE 80 
PEG-100 STEARATE 
HYDROGENATED PALM KERNEL OIL 
Packaging
#Item CodePackage Description
1NDC:0472-1203-5050 SUPPOSITORY (50 SUPPOSITORY) in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01833704/01/1980
Labeler - Actavis Mid Atlantic LLC (809515898)
Establishment
NameAddressID/FEIOperations
Actavis Mid Atlantic LLC809515898ANALYSIS(0472-1203), LABEL(0472-1203), MANUFACTURE(0472-1203), PACK(0472-1203)

Revised: 08/2013
 
Actavis Mid Atlantic LLC

Further information

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

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