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FEVERALL CHILDREN  - acetaminophen suppository 
Actavis Mid Atlantic LLC

FeverAll ® (Acetaminophen Suppositories) CHILDREN

ACTIVE INGREDIENT

Acetaminophen 120 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 5 doses in 24 hours, which is the maximum daily amount
  • 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 5 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 3 years Do not use unless directed by a doctor
    3 to 6 years Use 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

Children’s

Ages 3-6 years

120 mg

See New Warnings Information

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

6 Rectal Suppositories

120 mg each

c72a221b-figure-01
c72a221b-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®.

c72a221b-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. 2023/1/2

40-11600

Rev. 8/08

VC3350


FEVERALL CHILDREN 
acetaminophen  suppository
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0472-1201
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE  
POLYSORBATE 80  
HYDROGENATED PALM KERNEL OIL  
PEG-100 STEARATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0472-1201-06 6 SUPPOSITORY In 1 BOX None
2 0472-1201-50 50 SUPPOSITORY In 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA018337 04/01/2023

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