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  5. Label Information: Childrens Dimetapp Cold And Cough

FDA Label for Childrens Dimetapp Cold And Cough

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

Childrens Dimetapp Cold And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Family Dollar Services 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, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl , 5 mg


Purposes



Antihistamine

Cough suppressant

Nasal decongestant


Uses



  • ▪temporarily relieves:
  • ▪Nasal congestion
    • ▪runny nose
    • ▪cough
    • ▪sneezing
    • ▪itchy, watery eyes due to hay fever
    • ▪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
  • ▪cough that occurs with too much phlegm (mucus)
  • ▪a breathing problem or persistent 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 any other oral nasal decongestant or stimulant
  • ▪taking sedatives or tranquilizers

When Using This Product



  • ▪do not use more than directed
  • ▪may cause marked drowsiness
  • ▪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



  • •nervousness, dizziness, or sleeplessness occurs
  • •symptoms do not get better within 7 days or are 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



anhydrous 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 55319-645-04

Children's

Cold
& Cough

Brompheniramine maleate (Antihistamine)
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)

Relieves Nasal Symptoms

  • •Stuffy Nose
  • •Runny Nose
  • •Sneezing

    • Plus Other Symptoms

    • •Itchy, Watery Eyes
    • •Cough

      • For Ages 6 Years and Over

      Grape Flavor

      Naturally and Artificially Flavored

      4 FL OZ (118 ml)

      Distributed by:

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

      Children's Cold & Cough 4 FL OZ 118 mL - dimetapp 02

      Children's Cold & Cough 4 FL OZ 118 mL - dimetapp 02


* Please review the disclaimer below.