delsym ®

delsym ®
SPL v3
SPL
SPL Set ID a43d59f9-3a6c-4a7c-b98d-b86d6035f716
Route
oral
Published
Effective Date 2021-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (15 mg)
Inactive Ingredients
fd&c yellow no. 6 hypromellose, unspecified isomalt magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified povidone, unspecified silicon dioxide titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: D Shape: oval Color: orange Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-07-01

Purpose

Cough suppressant

Description

Drug Facts


Medication Information

Purpose

Cough suppressant

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

Description

Drug Facts

Questions?

1-866-682-4639

You may also report side effects to this phone number.

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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.

Section 50570-1

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.

Section 53414-9

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

Active Ingredient (in Each Caplet)

Dextromethorphan HBr 15 mg

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)
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+


Structured Label Content

Purpose

Cough suppressant

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 (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (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.

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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.

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Dextromethorphan HBr 15 mg

Ask A Doctor Before Use If You Have (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)
Principal Display Panel 20 Caplet Blister Pack Carton (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+


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)