FDA Label for Walgreens Grape Flavor

View Indications, Usage & Precautions

Walgreens Grape Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 20 Ml)



Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg


Purposes



Cough suppressant
Expectorant


Uses



  • ▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • ▪helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Do Not Use



If your are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


Ask A Doctor Before Use If You Have



  • ▪cough that occurs with too much phlegm (mucus)
  • ▪cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop Use And Ask A Doctor If



cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).


Directions



  • ▪do not take more than 6 doses in any 24-hour period
  • ▪measure only with dosing cup provided
  • ▪keep dosing cup with product
  • ▪mL = milliliter
  •  Age

    Dose

    children under 4 years

    do not use

    children 4 to under 6 years

    5 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    adults and children 12 years and older

    20 mL every 4 hours


Other Information



  • •each 20 mL contains: sodium 10 mg
  • •low sodium
  • •store at room temperature. Do not refrigerate.

Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.


Questions Or Comments



1-866-467-2748


Package Label-Principal Display Panel - 4 Fl Oz (118 Ml Bottle)



Walgreens
 

Compare to the Children's Robitussin® Cough & Chest Congestion DM active ingredients††

NDC 0363-7470-04

Children'sCOUGH& CHESTCONGESTION

Dye-Free

Wal-Tussin® DM

DEXTROMETHORPHAN HBr,
USP 20 mg/COUGH SUPPRESSANT
GUAIFENESIN, USP 200 mg/EXPECTORANT

DYE FREE

ALCOHOL FREE

NON-DROWSY

  • •Relief from cough chest congestion & mucus
  • 4 YEARS & OLDER

    GRAPE FLAVOR

    NATURALLY & ARTIFICIALLY FALVORED

    4 FL OZ (118 mL)

    TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

    †Walgreens Pharmacist Survey

    ††This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin® Cough & Chest Congestion DM.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens

    100% SATISFACTION GUARANTEED

    Walgreens.com ©2019 Walgreen Co.


* Please review the disclaimer below.