DELSYM COUGH- dextromethorphan hydrobromide tablet

Delsym Cough by

Drug Labeling and Warnings

Delsym Cough by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

Warnings

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)

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.

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

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.

SPL UNCLASSIFIED SECTION

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

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+

INGREDIENTS AND APPEARANCE

DELSYM COUGH 
dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-351
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ISOMALT (UNII: S870P55O2W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-351-20	1 in 1 CARTON	07/01/2021
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2021

Labeler - RB Health (US) LLC (081049410)