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Childrens Pain Relief by QUALITY CHOICE (Chain Drug Marketing Association)

Medically reviewed on Mar 28, 2018

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-174

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.

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

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

Warnings

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 fight away.

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

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 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
  • 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 right away (1-800-222-1222). Quick 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
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • 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
 Weight (lb) Age (year) Dose (mL)*
 under 24 under 2 ask a doctor
 24-35 2-3 5mL
 36-47 4-5 7.5 mL
 48-59 6-8 10 mL
 60-71 9-10 12.5 mL
 72-95 11 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

anhydrous citric acid,butylparaben, carboxymethylcellulose sodium, D&C red 33, FD&C blue 1, flavors, glycerin, high fructose corn syrup, microcrystaline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

 Call1-248-449--9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

Children's Pain Relief

Pain Reliever and Fever Reducer

Acetaminophen

160 mg per 5 mL

Oral Suspension

For Ages 2-11

Aspirin Free

Alcohol Free

Ibuprofen Free

Grape Flavor

FL OZ (mL)

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A. Inc.©

43157 W. Nine Mile

Novi. MI 48376-0995

www.qualitychocie.com

Product Label

QUALITY CHOICE Children's Pain Relief Grape Flavor

CHILDRENS PAIN RELIEF 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-174
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C BLUE NO. 1 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-174-18118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34310/31/2014
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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Further information

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

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