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  5. Label Information: Childrens Robitussin Cough And Cold Long-acting

FDA Label for Childrens Robitussin Cough And Cold Long-acting

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML TSP)
    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. PRODUCT PACKAGING

Childrens Robitussin Cough And Cold Long-acting Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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 5 Ml Tsp)



Chlorpheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 7.5 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.


Directions



  • do not take more than 4 doses in any 24-hour period
    • agedose
    under 6 yearsdo not use
    6 to under 12 years2 teaspoons every 6 hours
    12 years and older4 teaspoons every 6 hours

Other Information



  • each teaspoon contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • dosage cup provided

Inactive Ingredients



anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, lactic acid, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose


Questions Or Comments?



Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675


Product Packaging



The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

See New Dosing Information

Children’s Robitussin Cough & Cold LONG-ACTING

CHLORPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

RELIEVES:

Cough: Up to 8 Hours

Runny Nose

FRUIT PUNCH Flavor

For Children Ages 6 & Over

Alcohol-Free

4 FL OZ (118 mL)

Robitussin Knows

Choosing the right product is important. Robitussin has different products for adults and for children.

GREEN Boxes

Ages 12 & Over

RED Boxes

Ages Under 12

Use as directed

DOSAGE CUP INCLUDED

Wyeth Consumer Healthcare Madison, NJ 07940 U.S.A. © 2009 Wyeth

For most recent product information, visit www.robitussin.com

PARENTS: Learn about teen medicine abuse www.stopMedicineAbuse.org

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.


* Please review the disclaimer below.