long-lasting cough relief

Drug Facts

Composition & Product

Active Ingredients

dextromethorphan (15 mg)

Inactive Ingredients

fd&c blue no. 1 fd&c red no. 40 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2016-07-06

Medication Information

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

age	dose
adults and children 12 years and over	take 2 softgels every 6 to 8 hours, as needed
children under 12 years	do not use

Other Information

store at room temperature 15-30°C (59-86°F)
avoid excessive heat above 40°C (104°F)
protect from light

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Description

Drug Facts

Principal Display Panel

ADULT LONG-LASTING Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 51013-161-15

^*Compare to the active ingredient in Robitussin^® Lingering Cold Long-Acting CoughGels^®

Use

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

Section 42229-5

Drug Facts

Section 50566-9

Stop use and ask a 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?

Call toll free: 1-855-215-8180

Keep Out of Reach of Children.

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

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 15 mg

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 softgels in any 24-hour period
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	take 2 softgels every 6 to 8 hours, as needed
children under 12 years	do not use

Other Information (Other information)

store at room temperature 15-30°C (59-86°F)
avoid excessive heat above 40°C (104°F)
protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT LONG-LASTING Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 51013-161-15

^*Compare to the active ingredient in Robitussin^® Lingering Cold Long-Acting CoughGels^®

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 50566-9 (50566-9)

Stop use and ask a 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?)

Call toll free: 1-855-215-8180

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

Dextromethorphan HBr, USP 15 mg

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

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Raw Label Data

All Sections (JSON)

{"Use": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.", "42229-5": "Drug Facts", "50566-9": "Stop use and ask a 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.", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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 age dose adults and children 12 years and over take 2 softgels every 6 to 8 hours, as needed children under 12 years do not use", "Other information": "store at room temperature 15-30°C (59-86°F) avoid excessive heat above 40°C (104°F) protect from light", "Inactive ingredients": "FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink", "Questions or comments?": "Call toll free: 1-855-215-8180", "PRINCIPAL DISPLAY PANEL": "ADULT LONG-LASTING Cough Relief Dextromethorphan HBr, USP 15 mg 20 Softgels NDC 51013-161-15 * Compare to the active ingredient in Robitussin ® Lingering Cold Long-Acting CoughGels ®", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each softgel)": "Dextromethorphan HBr, USP 15 mg", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information