LITTLE REMEDIES INFANT 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 REMEDIES INFANT FEVER PAIN RELIEVER - Berry

Drug Facts

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily:

Warnings

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

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If 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, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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.

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.

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

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

mL=mililiter

Weight (lbs)Age (yrs)Dose
Under 24Under 2Ask a doctor
24-352-35 mL

Other information

Inactive ingredients

benzoic acid, carboxymethlcellulose, glycerin, natural berry flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

Questions?

1-800-54-8853 Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST

LittleRemedies.com

PRINCIPAL DISPLAY PANEL


Little Remedies®
INFANT

FEVER+PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural berry flavor
2 FL OZ (59 mL)

PRINCIPAL DISPLAY PANEL

Little Remedies®
INFANT
FEVER+PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural berry flavor
2 FL OZ (59 mL)

LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-610
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-610-011 in 1 BOX07/01/2011
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:63029-610-022 in 1 CARTON07/01/2011
259 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/01/2011
Labeler - Medtech Products Inc. (122715688)

Revised: 1/2020
Document Id: f4529240-a615-4d1a-a07f-f27f87d3334f
Set id: af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a5
Version: 2
Effective Time: 20200101
 
Medtech Products Inc.