LITTLE FEVERS INFANT BERRY FEVER/PAIN RELIEVER- acetaminophen liquid 
Medtech Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Little Fevers Infant Berry Fever Pain Reliever

Drug Facts

Active ingredient

(in each 5.0 mL)

Acetaminophen 160mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily:

Warnings

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

Ask a doctor before use

if your child has liver disease.

Ask a doctor or pharmacist before use

if your child is taking the blood thinning drug warfarin.

Do not use:

  • with any other products containing acetaminophen (prescription or non-prescription). 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.

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

When using this product

DO NOT EXCEED RECOMMENDED DOSAGE; taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.

Stop use and ask a doctor if:

  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 5 days
  • 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) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

This product does not contain directions or complete warnings for adult use.

Weight (lbs)Age (yrs)Dose
Under 24Under 2Ask a doctor
24-352-35.0 mL
36-474-57.5 mL

Other information

Inactive ingredients

Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, Polyethylene Glycol, Propylene Glycol, Purified Water, Sodium Benzoate and Sucralose

Questions?

For further information you may contact us at: 1-800-7-LITTLE Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.

PRINCIPAL DISPLAY PANEL

MEDICATED FOR INFANTS
Little Fevers® by Little Remedies®
NEW! AccuSafeTM System
INFANT FEVER/PAIN RELIEVER
Acetaminophen
DYE-FREE
NO ARTIFICIAL FLAVORS
NO ALCOHOL, SACCHARIN OR DYES
GLUTEN FREE!
Natural BERRY Flavor
SEE NEW DOSING INFORMATION.
2 FL. OZ. (59 mL)

PRINCIPAL DISPLAY PANEL
Little Fevers® by Little Remedies®
INFANT FEVER/PAIN RELIEVER
Acetaminophen
Natural BERRY Flavor
2 FL. OZ. (59 mL)

LITTLE FEVERS INFANT BERRY FEVER/PAIN RELIEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-622
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
CITRIC ACID (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-622-011 in 1 BOX
11 in 1 BOX
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/01/2011
Labeler - Medtech Products Inc. (122715688)

Revised: 7/2011
Document Id: ed6e84da-f9ef-47d3-83cd-77d5a7c804d2
Set id: 9c17dde6-eafe-494b-b7ec-cd930274d8cc
Version: 1
Effective Time: 20110702
 
Medtech Products Inc.