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FeverALL Infants by Actavis Mid Atlantic LLC

Dosage form: suppository
Ingredients: ACETAMINOPHEN 80mg
Labeler: Actavis Mid Atlantic LLC
NDC Code: 0472-1200

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
 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

FEVERALL INFANTS 
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:0472-1200-066 SUPPOSITORY (6 SUPPOSITORY) in 1 BOX
2NDC:0472-1200-5050 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(0472-1200), LABEL(0472-1200), MANUFACTURE(0472-1200), PACK(0472-1200)

Revised: 08/2013
 
Actavis Mid Atlantic LLC

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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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