FDA Label for Cvs Pharmacy Childrens Cold And Allergy

View Indications, Usage & Precautions

Cvs Pharmacy Childrens Cold And Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. 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, USP 2 mg


Purposes



Antihistamine


Uses



  • ▪temporarily relieves:
    • ▪runny nose
    • ▪sneezing
    • ▪itchy, watery eyes due to hay fever
    • ▪itching of the nose or throat

Do Not Use



  • ▪to sedate a child or to make a child sleepy

Ask A Doctor Before Use If You Have



  • ▪trouble urinating due to an enlarged prostate gland
  • ▪glaucoma
  • ▪a breathing problem such as emphysema, or chronic bronchitis.

Ask A Doctor Or Pharmacist Before Use If You Are



  • ▪taking sedatives or tranquilizers

When Using This Product



  • do not use more than directed
  • ▪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

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, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose


Questions Or Comments?



1-866-467-2748


Principal Display Panel - 118 Ml Bottle Label



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

NDC# 51316-693-04

Children'sCold & Allergy

Brompheniramine Maleate USP (Antihistamine)
Relieves + comforts:

  • Runny Nose
  • Itchy, Watery Eyes
  • Sneezing
  • Itchy throat
  • For Ages 6 Years and Over

    Grape Flavor

    Naturally and Artificially Flavored

    No Added Alcohol

    No Added Sugar

    4 FL OZ (118 ml)

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

    Distributed by:

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


* Please review the disclaimer below.