0ffaa7d8-713f-4e4a-beca-2401de17de6f

SPL v3
SPL
SPL Set ID 0ffaa7d8-713f-4e4a-beca-2401de17de6f
Route
oral
Published
Effective Date 2021-02-05
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 k30 fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin sorbitol water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2021-02-05

Purpose

Cough suppressant

Description

Drug Facts


Medication Information

Warnings

Purpose

Cough suppressant

Directions
  • do not take more than 8 softgels 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

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, gelatin, glycerin, sorbitol, water

Description

Drug Facts

Principal Display Panel

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.

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.

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

Warnings

Purpose

Cough suppressant

Directions
  • do not take more than 8 softgels 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)

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, gelatin, glycerin, sorbitol, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.

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.

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)