FDA Label for Childrens Wal Tussin Cough And Cold

View Indications, Usage & Precautions

Childrens Wal Tussin Cough And Cold Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Co.. 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 10 Ml)



Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg


Purposes



Antihistamine

Cough suppressant


Uses



  • •temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • •temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • •runny nose
    • •sneezing
    • •itchy, watery eyes
    • •itching of the nose or throat

Do Not Use



  • •to sedate a child or to make a child sleepy
  • •if you 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have



  • •trouble urinating due to an enlarged prostate gland
  • •glaucoma
  • •a cough that occurs with too much phlegm (mucus)
  • •a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • do not use more than directed
  • •marked drowsiness may occur
  • •avoid alcoholic drinks
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery
  • •excitability may occur, especially in children

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



  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •mL = milliliter
  • •do not take more than 4 doses in any 24-hour period
  • agedose

    Children under 6 years

    do not use

    children 6 to under 12 years

    10 mL every 6 hours

    adults and children 12 years and older

    20 mL every 6 hours


Other Information



  • •each 10 mL contains: sodium 7 mg
  • •store at room temperature, Do not refrigerate.
  • •Do not use if printed seal under cap is torn or missing

Inactive Ingredients



citric acid, FD&C red no. 40,glycerin, lactic acid, natural and artificial flavors,

propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose


Questions Or Comments?



1-866-467-2748


Product Packaging



Walgreens

Compare to Children’s Robitussin® Cough & Cold Long–Acting active ingredients ††

New

children’s Wal-Tussin® Cough & Cold

CHLORPHENIRAMINE MALEATE USP 2 mg / Antihistamine

DEXTROMETHORPHAN HBr, USP 15 mg/ Cough Suppressant

  • •Relief of cough & runny nose
  •  6 YEARS & OLDER
  • FRUIT PUNCH FLAVOR

    NATURALLY AND ARTIFICIALLY FLAVORED

    6 YEARS & OLDER

    4 FL OZ (118 mL)

    WALGREENS PHARMACIST RECOMMENDED

    Walgreens Pharmacist Survey

    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

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