FEVERALL  CHILDRENS- acetaminophen suppository 
Taro Pharmaceuticals U.S.A. Inc.

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Feverall®
Children's

Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 120 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

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

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 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

Dosing Chart
AgeDose
under 3 yearsDo not use unless directed by a doctor
3 to 6 yearsUse 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?

call 1-866-923-4914

Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton

NDC 51672-2115-2

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

Pain Reliever/Fever Reducer

No Parabens or Any Other Preservatives
No Artificial Colors

CHILDREN'S

ages 3-6 years

FeverAll®

ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

6
Rectal
Suppositories

120
mg
each

PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton
FEVERALL   CHILDRENS
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2115
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen120 mg
Inactive Ingredients
Ingredient NameStrength
glyceryl monostearate (UNII: 230OU9XXE4)  
hydrogenated palm kernel oil (UNII: FM8D1RE2VP)  
PEG-100 stearate (UNII: YD01N1999R)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2115-26 in 1 CARTON12/12/2013
1NDC:51672-2115-01 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51672-2115-450 in 1 CARTON12/12/2013
2NDC:51672-2115-01 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01833712/12/2013
Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
G&W NC Laboratories, Inc.079419931MANUFACTURE(51672-2115)

Revised: 7/2019
Document Id: f78b5761-ee3c-4a98-b152-cd0d2b08faa9
Set id: 861e2987-5473-45b0-b2a6-f980a9b0e809
Version: 5
Effective Time: 20190726
 
Taro Pharmaceuticals U.S.A. Inc.