FEVERALL INFANTS - acetaminophen suppository 
Actavis Mid Atlantic LLC

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ACTIVE INGREDIENT

Acetaminophen 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

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 2(-27(C (35(-80(F)
  • 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 (select option #2) between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Infants’

Ages 6-36 months

80 mg

See New Warnings Information

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

6 Rectal Suppositories

80 mg each

43c9e456-figure-01
43c9e456-figure-02

6 RECTAL SUPPOSITORIES CARTON LABEL

CONSUMER INSTRUCTIONS

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

DIRECTIONS: When practical, cleanse area around rectum with mild soap and warm water and rinse thoroughly.  Gently dry by patting or blotting with toilet tissue or a soft cloth before using FeverAll®.

43c9e456-figure-03
  1. Remove wrapper before inserting suppository as follows:  hold suppository upright and carefully separate wrapper at pointed end to open.
  2. Carefully peel wrapper down both sides evenly, exposing suppository.
  3. Avoid excess handling, as suppository is designed to melt at body temperature.  Suppositories should not need to be refrigerated if stored below 80(F (27(C).
  4. Place child flat on back or on side with anal opening exposed.
  5. Insert suppository gently, well into rectum.  Use fingertip to complete insertion.

Questions? 1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday – Friday.

Distributed by:

Actavis Mid Atlantic LLC

1877 Kawai Road,

Lincolnton, NC 28092 USA

FORM NO. 1200/1/2

40-11600

Rev. 8/08

VC3350

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
GLYCERIN 
POLYSORBATE 80 
HYDROGENATED PALM KERNEL OIL 
PEG-100 STEARATE 
Packaging
#Item CodePackage Description
1NDC:0472-1200-066 in 1 BOX
2NDC:0472-1200-5050 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA01833705/01/1980
Labeler - Actavis Mid Atlantic LLC (809515898)

Revised: 02/2012
 
Actavis Mid Atlantic LLC