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  5. Label Information: Cvs Childrens Cold And Allergy

FDA Label for Cvs Childrens Cold And Allergy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 10 ML)
    2. PURPOSES
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL

Cvs 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

Phenylephrine HCl, USP 5 mg


Purposes



Antihistamine

Nasal Decongestant


Uses



  • ▪temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • ▪temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • ▪runny nose
    • ▪sneezing
    • ▪itchy, watery eyes
    • ▪itching of the nose or throat
    • ▪temporarily restores freer breathing through the nose

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



  • ▪heart disease
  • ▪high blood pressure
  • ▪thyroid disease
  • ▪diabetes
  • ▪trouble urinating due to an enlarged prostate gland
  • ▪glaucoma
  • ▪a breathing problem such as emphysema, asthma, or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are



  • ▪taking any other oral nasal decongestant or stimulant
  • ▪taking sedatives or tranquilizers

When Using This Product



  • ▪do not use more than directed
  • ▪drowsiness may occur
  • ▪avoid alcoholic beverages
  • ▪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



  • ▪you get nervous, dizzy, or sleepless
  • ▪symptoms do not get better within 7 days or are accompanied by fever

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



anhydrous 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# 69842-639-04

Children'sCold & Allergy

Brompheniramine Maleate USP (Antihistamine)
Phenylephrine HCl USP (Nasal Decongestant)

  • •Stuffy Nose
  • •Runny Nose
  • •Sneezing
  • •Itchy, Watery Eyes

    • Alcohol-Free • Sugar Free

    Ages 6 Years and Over

    Grape Flavor

    Naturally and Artificially Flavored

    4 FL OZ (118 ml)

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

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2020 CVS/pharmacy

    CVS.com 1-800-SHOP CVS

    V12431

    CVS Quality

    Money Back Guaranteed

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

    CVS Childrens Cold and Allergy Relief Dimetapp - childrens 01

    CVS Childrens Cold and Allergy Relief Dimetapp - childrens 01


* Please review the disclaimer below.