Robitussin Nighttime Cough Dm Soft Chews Tablet, Chewable
FDA Label NDC 0031-9311

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Nighttime Cough Dm Soft Chews (NDC 0031-9311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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