Childrens Wal Tussin Cough And Cold
FDA Label NDC 0363-0745

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Childrens Wal Tussin Cough And Cold (NDC 0363-0745). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 10 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    Walgreens 100% SATISFACTION GUARANTEED

    walgreens.com ©2017 Walgreen Co.

    Childrens Wal- Tussin Cough & Cold 4 Fl Oz Fruit Punch Flavor (Paa009240)

    Childrens Wal- Tussin Cough & Cold 4 Fl Oz Fruit Punch Flavor (Paa009240)

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