FDA Label for Target Childrens Cold And Cough

View Indications, Usage & Precautions

Target Childrens Cold And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Target Corporation. 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)



Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg


Purposes



Antihistamine

Cough suppressant


Uses



  • temporarily relieves:
    • runny nose
    • cough
    • sneezing
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • itching of the nose or throat
    • temporarily alleviates the intensity of coughing

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
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such 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
  • may cause marked drowsiness
  • 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



  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosage cup with product
  • ml = milliliter
  • agedose

    adults and children 12 years and over

    20 ml every 4 hours

    children 6 to under 12 years

    10 ml every 4 hours

    children under 6 years

    do not use


Other Information



  • each 10 ml contains: sodium 6 mg
  • store at room temperature.

Inactive Ingredients



citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose


Questions Or Comments?



1-866-467-2748


Principal Display Panel



Compare to the active ingredients in Children’s Dimetapp® Cold & Cough*

NDC 82442-654-04

Children's

Cold
& Cough

Brompheniramine maleate(Antihistamine)
Dextromethorphan HBr(Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery Eyes
  • Sneezing
  • Cough
  • For Ages 6 Years and Over

    No Added Alcohol

    Grape Flavor

    Naturally and Artificially Flavored

    8 FL OZ (236 ml)

    IMPORTANT: Keep this carton for future reference on full labelling.

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

    Distributed by:

    *This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Cough.


* Please review the disclaimer below.