safrel cough relief dextromethorphan hbr 15 mg

safrel cough relief dextromethorphan hbr 15 mg
SPL v1
SPL
SPL Set ID f4cc6a9d-c093-4373-e053-2a95a90a1ca6
Route
oral
Published
Effective Date 2019-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: IS3 Shape: oval Color: red Size: 13 mm Score: 1
Marketing Status
otc monograph final active Since 2022-10-28
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

Safrel Dextromethorphan Softgels 15 mg - 100 ct

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?

1-844-384-3723

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)

Safrel Dextromethorphan Softgels 15 mg - 100 ct

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?)

1-844-384-3723

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: 2026-02-15T12:00:34.624429 · Updated: 2026-03-14T23:01:03.935839