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  5. Label Information: Childrens Robitussin Nighttime Cough Long-acting Dm

FDA Label for Childrens Robitussin Nighttime Cough Long-acting Dm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 10 ML)
    2. PURPOSES
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. STORAGE AND HANDLING
    14. INACTIVE INGREDIENT
    15. OTC - QUESTIONS
    16. OTHER
    17. PRINCIPAL DISPLAY PANEL

Childrens Robitussin Nighttime Cough Long-acting Dm 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 10 Ml)



Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg


Purposes



Antihistamine

Cough suppressant


Indications & Usage



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

Warnings



Warnings


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

Otc - Ask Doctor/Pharmacist



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

Otc - Stop Use



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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •ml = milliliter
  • •do not take more than 4 doses in any 24-hour period
    • agedose

    children under 6 years

    do not use

    children 6 to under 12 years

    10 ml every 6 hours

    adults and children 12 years and older

    20 ml every 6 hours


Storage And Handling



Other information

  • •each 10 ml contains: sodium 6 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredient



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


Otc - Questions



Questions or comments?

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

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


Other



Distributed by:
Pfizer, Madison, NJ 07940 USA


Principal Display Panel



Children's

Robitussin®

AGES 6 & OVER

Nighttime
Cough

Long-Acting

DM

CHLORPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves Cough up to 8 Hours
& Runny Nose

Alcohol-Free

Fruit punch flavor

4 FL OZ (118 ml)

Robitussin Ch NT 4 FL OZ (118 ml) - image 01

Robitussin Ch NT 4 FL OZ (118 ml) - image 01


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