Delsym Cough Tablet
FDA Label NDC 72854-351

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Delsym Cough (NDC 72854-351). 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 other, active ingredient (in each caplet), purpose, use, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in India

Active Ingredient (In Each Caplet)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Use

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep

Otc - Do Not Use

Do not use 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

  • chronic cough that lasts such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with 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.

Directions

  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over:
    take 2 caplets every 6 to 8 hours as needed, not to exceed 8 caplets in 24 hours
  • children under 12 years of age:
    do not use

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

FD&C yellow no. 6 aluminum lake, hypromellose, isomalt, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide

Questions?

1-866-682-4639

You may also report side effects to this phone number.

Principal Display Panel - 20 Caplet Blister Pack Carton

MAXIMUM STRENGTH

NEW!

NDC 72854-351-20

Delsym®

COUGH
Dextromethorphan HBr (Cough Suppressant)

LASTS
UP
TO
8HR

DAY
OR
NIGHT

FAST
RELEASE

Actual Size

20 Caplets
For Ages 12+

Principal Display Panel (20 Caplet Blister Pack Carton)

Principal Display Panel (20 Caplet Blister Pack Carton)

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