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

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Feverall®
Adults

Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 650 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

  • 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 12 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

Other information

Inactive ingredients

glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

Questions?

call 1-866-923-4914

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

PRINCIPAL DISPLAY PANEL - 50 Suppository Carton

ADULTS'
ages 12 years & older

FeverAll®
ACETAMINOPHEN
SUPPOSITORIES

Pain Reliever/Fever Reducer

NOT FOR RETAIL SALE
NDC 51672-2117-4

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

50
Rectal
Suppositories

650
mg
each

Principal Display Panel - 50 Suppository Carton
FEVERALL   ADULTS
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2117
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 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:51672-2117-450 in 1 CARTON12/12/2013
1NDC:51672-2117-01 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(51672-2117)

Revised: 5/2016
Document Id: c107ee4d-6fd8-4cd8-9f80-5d140801eaba
Set id: 7afa4b78-5e14-4723-a87b-01f664b0c0e9
Version: 6
Effective Time: 20160519
 
Taro Pharmaceuticals U.S.A. Inc.