FEVERALL- acetaminophen suspension 
TARO PHARMACEUTICALS U.S.A., INC.

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FeverAll ®

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 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.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child hasliver disease

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (yr)Dose (mL) *
*
or as directed by a doctor
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NEW

ORAL
SUSPENSION
LIQUID

NDC 51672-5319-8

CHILDREN'S
ages 2-11 years

FeverAll ®
ACETAMINOPHEN (160 mg/5 mL)

Pain Reliever/Fever Reducer
Oral Suspension

Cherry Flavor

DOSING CUP
ENCLOSED

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
FEVERALL 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-5319
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-5319-81 in 1 CARTON06/01/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/01/2023
Labeler - TARO PHARMACEUTICALS U.S.A., INC. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295manufacture(51672-5319)

Revised: 11/2024
Document Id: 26b92714-c652-943d-e063-6394a90a8341
Set id: 8970b91b-5f3c-4764-9e23-25dcb398d0a7
Version: 3
Effective Time: 20241112
 
TARO PHARMACEUTICALS U.S.A., INC.