Your browser does not support JavaScript! FEVERALL INFANTS (ACETAMINOPHEN) SUPPOSITORY [ACTAVIS MID ATLANTIC LLC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

FEVERALL INFANTS (acetaminophen) suppository
[Actavis Mid Atlantic LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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
 Age Dose
 under 6 months Do not use unless directed by a doctor
 6 to 11 months Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours)
 12 to 36 months Use 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 DRUG LABELItem Code (Source)NDC:0472-1200
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
POLYSORBATE 80 
HYDROGENATED PALM KERNEL OIL 
PEG-100 STEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0472-1200-066 in 1 BOX
2NDC:0472-1200-5050 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/FEIBusiness Operations
Actavis Mid Atlantic LLC809515898ANALYSIS(0472-1200), LABEL(0472-1200), MANUFACTURE(0472-1200), PACK(0472-1200)

Revised: 8/2013
 
Actavis Mid Atlantic LLC

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services