FEVERALL INFANTS- acetaminophen suppository 
Actavis Pharma, Inc.

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FeverAll ® (Acetaminophen Suppositories) INFANTS

ACTIVE INGREDIENT

Acetaminophen, USP 80 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 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months
  • more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months
  • 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 3 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 6 monthsDo not use unless directed by a doctor
6 to 11 monthsUse 1 suppository every 6 hours (maximum of 4 doses in 24 hours)
12 to 36 monthsUse 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

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

Infants’

Ages 6-36 months

80 mg

NDC 0472-1200-06

FeverAll ®

Acetaminophen Suppositories

Pain reliever/fever reducer

6 Rectal Suppositories

80 mg each

1
FEVERALL INFANTS 
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1200
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0472-1200-066 in 1 BOX; Type 0: Not a Combination Product04/01/198001/31/2016
2NDC:0472-1200-5050 in 1 BOX; Type 0: Not a Combination Product04/01/198006/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01833704/01/198001/31/2016
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 3/2018
 
Actavis Pharma, Inc.