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

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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