FEVERALL INFANTS- acetaminophen suppository 
Actavis Mid Atlantic LLC

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FeverAll ® (Acetaminophen Suppositories) INFANTS

ACTIVE INGREDIENT

Acetaminophen, USP 80 mg

PURPOSES

Pain reliever/fever reducer

USES

Temporarily

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

For rectal use only

DO NOT USE

ASK A DOCTOR BEFORE USE IF

STOP USE AND ASK A DOCTOR IF

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

 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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1200
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0472-1200-06 6 in 1 BOX
2 NDC:0472-1200-50 50 in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018337 04/01/1980
Labeler - Actavis Mid Atlantic LLC (809515898)
Establishment
Name Address ID/FEI Business Operations
Actavis Mid Atlantic LLC 809515898 ANALYSIS(0472-1200) , LABEL(0472-1200) , MANUFACTURE(0472-1200) , PACK(0472-1200)

Revised: 8/2013
Document Id: 107ec71c-fe08-4ea0-92a7-244b5386b353
Set id: 2f1d555e-ad12-4b3c-9b2f-d824fed38400
Version: 8
Effective Time: 20130822
 
Actavis Mid Atlantic LLC