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 Sorbitan

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2017-07-13

Medication Information

Purpose

Cough suppressant

Description

Drug Facts

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.

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 sorbitan solution and white edible ink

Questions Or Comments?

Call toll free: 248-449-9300

Principal Display Panel

ADULT LONG-LASTING Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 63868-222-20

*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

Structured Label Content

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.

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 sorbitan solution and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free: 248-449-9300

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT LONG-LASTING Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 63868-222-20

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

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 sorbitan solution and white edible ink", "Questions or comments?": "Call toll free: 248-449-9300", "PRINCIPAL DISPLAY PANEL": "ADULT LONG-LASTING Cough Relief Dextromethorphan HBr, USP 15 mg 20 Softgels NDC 63868-222-20 *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