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FEVERALL ADULTS  - acetaminophen suppository 
Actavis Mid Atlantic LLC

FeverAll ® (Acetaminophen Suppositories) ADULTS

OTC - ACTIVE INGREDIENT

Acetaminophen, USP 650 mg

OTC - 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

For rectal use only

OTC - 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

OTC - ASK DOCTOR

  • you have liver disease.
  • you are taking the blood thinning drug warfarin.

OTC - 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.

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - 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 INGREDIENT

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

OTC - 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

See New Warnings Information

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

50 Rectal Suppositories

650 mg each

6cc62324-figure-01

50 RECTAL SUPPOSITORIES CARTON LABEL


FEVERALL ADULTS 
acetaminophen  suppository
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0472-1203
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE  
POLYSORBATE 80  
PEG-100 STEARATE  
HYDROGENATED PALM KERNEL OIL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0472-1203-50 50 SUPPOSITORY In 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018337 04/01/2023

Labeler - Actavis Mid Atlantic LLC (809515898)
Revised: 02/2012Actavis Mid Atlantic LLC