cough relief

cough relief
SPL v4
SPL
SPL Set ID b05ca9da-e3df-4a44-8c5a-602e0c91cd46
Route
oral
Published
Effective Date 2023-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (15 mg)
Inactive Ingredients
propylene glycol povidone, unspecified gelatin glycerin polyethylene glycol 400 sorbitol fd&c red no. 40 titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 404;904 Shape: oval Color: red Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-01-03
Purpose

Cough suppressant

Description

Drug Facts

Medication Information

Purpose

Cough suppressant

Directions
  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed
children under 12 years do not use
Other Information
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light
Inactive Ingredients

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan solution, titanium dioxide

Description

Drug Facts

Principal Display Panel

Cough Relief

Dextromethorphan HBr 15mg

60 softgels

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by 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.

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 15mg

Ask A Doctor Before Use If You Have
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Structured Label Content

Purpose

Cough suppressant

Directions
  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed
children under 12 years do not use
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light
Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan solution, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Cough Relief

Dextromethorphan HBr 15mg

60 softgels

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

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 orcontact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by 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.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Dextromethorphan HBr, USP 15mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:45.844520 · Updated: 2026-03-14T23:05:41.137982