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  5. Label Information: Robitussin Nighttime Cough Dm Soft Chews

FDA Label for Robitussin Nighttime Cough Dm Soft Chews

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    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. ADDITIONAL INFORMATION
    17. PRINCIPAL DISPLAY PANEL

Robitussin Nighttime Cough Dm Soft Chews 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.

Otc - Active Ingredient



Active ingredients (in each chewable tablet)

Dextromethorphan equivalent to dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Otc - Purpose



Purposes

Cough suppressant

Antihistamine


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
    • controls the impulse to cough to help you sleep

Warnings



Warnings


Otc - Do Not Use



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 is chronic such as occurs with smoking, asthma, or chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • 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 ifcough 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

  • do not take more than 4 doses (8 chewable tablets) in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
    • agedose

    adults and children

    12 years and over

    take 2 chewable tablets every 6 hours, as needed

    children under 12 years

    do not use


Storage And Handling



Other information

  • each chewable tablet contains:potassium 10 mg, sodium 7 mg
  • store at a controlled room temperature 20-25°C (68-77°F)

Inactive Ingredient



Inactive ingredients

carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, D&C red no. 30 aluminum lake, FD&C blue no. 1 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk


Otc - Questions



Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040


Additional Information



Do Not Use if seal under bottle cap imprinted with

“SEALED for YOUR PROTECTION” is broken or missing.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineabuse.org

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the Haleon group of companies.

Pat. Info www.productpats.com

©2023 Haleon group of companies or its licensor.

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


Principal Display Panel



NEW! ADULT HALEON

Robitussin

Nighttime Cough DM

Soft CHEWS

DEXTROMETHORPHAN HBr 15 mg
(Cough Suppressant)

DOXYLAMINE SUCCINATE 6.25 mg

(Antihistamine)

FAST relief ANYWHERE

Cough, runny nose & sneezing

UP TO 8HRCOUGH RELIEF

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

Berry flavor

208797 Front Label


* Please review the disclaimer below.