LITTLE REMEDIES CHILDRENS 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 Childrens Fever Pain Reliever

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 the 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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of symptoms.

Directions

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

Weight (lb)Age (yr)Dose
Under 24under 2Ask a doctor
24-352 – under 45mL
36-474 – under 67.5mL
48-596 – under 910 mL
60-719 – under 1112.5mL
72-9511 – under 12 15mL

Other information

Inactive ingredients

citric acid, glycerin, natural flavors, potassium sorbate, povidone, propylene glycol, purified water, sodium citrate, sucralose, sucrose, xanthan gum

Questions?

1-800-754-8853

Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST   LittleRemedies.com.

Principal Display Panel

Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL CHERRY FLAVOR
4 FL OZ (118 mL)

Little Remedies Childrens Fever Cherry Carton

Principal Display Panel

Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL GRAPE FLAVOR
4 FL OZ (118 mL)

Little Remedies Childrens Fever Grape Carton

LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-602
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 MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-602-021 in 1 CARTON09/01/2010
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 not finalpart34309/01/2010
LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-603
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 MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-603-021 in 1 CARTON09/01/2010
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 not finalpart34309/01/2010
Labeler - Medtech Products Inc. (122715688)

Revised: 2/2018
Document Id: c0a8a233-d8f6-4a39-ae56-3bc8cc747d16
Set id: e1e44c85-d10c-4997-8f85-064cda7906eb
Version: 4
Effective Time: 20180214
 
Medtech Products Inc.