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Childrens Pain Relief Dye-Free

Medically reviewed on May 24, 2017

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: WinCo Foods, LLC
NDC Code: 67091-119

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.

Childrens Pain Relief Oral Suspension Dye-Free Grape

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

Warnings

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

  • more than 5 doses in 24 hours, which is maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severeskin 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, or 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 non prescription). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist drugs.
  • 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 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
  • redness or swelling is present
  • new symptoms occur
  • 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 dose (see Overdose warning).

Stop use and ask a doctor if
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

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

Directions
  • this product does not contain directions or complete warnings for adult dose
  • do not take more than directed (see Overdose warning)
  • shake well before using
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every  4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  Weight (lb)  Age (year)  Dose (mL)*
  under 24 lbs  under 2 years  ask a doctor
  24-35 lbs  2-3   5 mL
  36-47 lbs  4-5   7.5 mL
  48 - 59 lbs  6-8   10 mL
  60 - 71 lbs  9-10   12.5 mL
  72 - 95 lbs  11 years  15 mL

*or as directed by a doctor

Other information
  • each 5 mL contains: sodium 2 mg
  • store between 20-25oC(68-77oF)
  • do not refrigerate
  • see bottom panel for lot number and expiration date

Inactive ingredients

butylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid,flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol,sucralose, xanthan gum

Questions?

Call 800-824-1706 Monday - Friday 9am - 4 pm MST

Principal Display Panel

**Compare to the active ingredient in Children's TYLENOL® Oral Suspension

ORAL SUSPENSION

Pain Relief

Children's

ACETAMINOPHEN 160 mg per 5 mL /

PAIN RELIEVER - FEVER REDUCER

Alcohol Free

Aspirin & Inuprofen Free

For Ages 2-11 Years

Dye Free

Grape Flavor

FL OZ (mL)

**This product is not manufactured or distributed by McNEIL CONSUMER HEALTHCARE, distributor of Children's TYLENOL® Oral Suspension.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AMD PRODUCT INFORMATION.

DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704

Comments or Question?

800-824-1706 www.wincofoods.com

Package label

WINCO FOODS Children's Pain Relief Dye Free Grape Flavor

CHILDRENS PAIN RELIEF DYE-FREE 
acteaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-119
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
GLYCERIN 
CARBOXYMETHYLCELLULOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
HIGH FRUCTOSE CORN SYRUP 
WATER 
SUCRALOSE 
XANTHAN GUM 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-119-181 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/12/2014
Labeler - WinCo Foods, LLC (056098817)

 
WinCo Foods, LLC

← See all Childrens Pain Relief Dye-Free brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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