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ROBITUSSIN Nighttime Cough DM Soft CHEWS (robitussin nighttime cough dm soft chews (dextromethorphan hydrobromide, doxylamine succinate) tablet, chewable) Dailymed

  1. Human OTC
    • Drug Classes
  3. Haleon US Holdings LLC

Generic: dextromethorphan hydrobromide, doxylamine succinate

ROBITUSSIN Nighttime Cough DM Soft CHEWS tablet, chewable - (robitussin nighttime cough dm soft chews (dextromethorphan hydrobromide, doxylamine succinate) tablet, chewable) image

IMPRINT: R     SHAPE: round
    COLOR: purple

  1. FDA Adverse Reactions

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Otc - Active Ingredient Section


Active ingredients (in each chewable tablet)

Dextromethorphan equivalent to dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Otc - Purpose Section


Purposes

Cough suppressant

Antihistamine

Indications & Usage Section


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 Section


Warnings

OTC - DO NOT USE SECTION


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 SECTION


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 SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Dosage & Administration Section


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
age dose

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 Section


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 Section


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 Section


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

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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