FEVERALL  JR. STRENGTH- acetaminophen suppository 
Taro Pharmaceuticals U.S.A. Inc.

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FeverAll®
Jr. Strength

Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 325 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if

  • a child 6 to 12 years takes more than 5 doses in 24 hours
  • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • an adult takes 3 or more alcoholic drinks every day while using this product

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

  • in children under 6 years
  • 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

  • you have liver disease.
  • you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • fever lasts more than 3 days (72 hours), or recurs.
  • pain gets worse or lasts more than 10 days.
  • new symptoms occur.
  • redness or swelling is present in the painful area.

These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. 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 6 yearsdo not use
6 to 12 yearsUse 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours)
adults and children 12 years and olderUse 2 suppositories every 4 to 6 hours. (maximum of 6 doses)

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 - 325 mg Suppository Blister Pack Carton

NDC 51672-2116-2

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

Pain Reliever/Fever Reducer

No Parabens or Any Other Preservatives
No Artificial Colors

JR. STRENGTH
ages 6-12 years

FeverAll®
ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

6
Rectal
Suppositories

325
mg
each

PRINCIPAL DISPLAY PANEL - 325 mg Suppository Blister Pack Carton
FEVERALL   JR. STRENGTH
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2116
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 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:51672-2116-26 in 1 CARTON12/12/2013
1NDC:51672-2116-01 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51672-2116-450 in 1 CARTON12/12/2013
2NDC:51672-2116-01 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(51672-2116)

Revised: 7/2019
Document Id: fbd0c378-6d46-4f6f-b473-610dd4d20bb1
Set id: 3561bbc3-53b0-4857-8b71-39e165ed95ce
Version: 5
Effective Time: 20190726
 
Taro Pharmaceuticals U.S.A. Inc.