Cough Suppressant

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Glycerin Isopropyl Alcohol Medium-chain Triglycerides Polyethylene Glycol, Unspecified Povidone, Unspecified Propyl Gallate Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-02-02

Medication Information

Purpose

Cough Suppressant

Description

Dextromethorphan HBr, USP 15 mg

Use

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

Section 42229-5

Compare to the active ingredient in Robitussin^® CoughGels^®**

Controls cough

Package Contains One Bottle

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2024 CVS/pharmacy

CVS.com^® 1-800-SHOP CVS

Product of United Arab Emirates

**This product is not manufactured or distributed by PF Consumer Healthcare LLC, owner of the registered trademark Robitussin^® CoughGels^®.

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Warnings

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.

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

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.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

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 softgels every 6 to 8 hours, as needed
children under 12 years	do not use

Drug Facts

Other Information

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

Call 1-800-SHOP-CVS

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 15 mg

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)

Compare to the active ingredient in Robitussin^® CoughGels^®**

Controls cough

Package Contains One Bottle

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2024 CVS/pharmacy

CVS.com^® 1-800-SHOP CVS

Product of United Arab Emirates

**This product is not manufactured or distributed by PF Consumer Healthcare LLC, owner of the registered trademark Robitussin^® CoughGels^®.

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purpose

Cough Suppressant

Warnings

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.

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

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.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

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 softgels every 6 to 8 hours, as needed
children under 12 years	do not use

Drug Facts

Other Information (Other information)

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

Call 1-800-SHOP-CVS

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

Dextromethorphan HBr, USP 15 mg

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": "Compare to the active ingredient in Robitussin ® CoughGels ®** Controls cough Package Contains One Bottle READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2024 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Product of United Arab Emirates **This product is not manufactured or distributed by PF Consumer Healthcare LLC, owner of the registered trademark Robitussin ® CoughGels ® .", "50565-1": "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.", "Purpose": "Cough Suppressant", "Warnings": "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. 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 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. 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 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 between 20°-25°C (68°-77°F) • protect from light, heat and moisture", "Inactive ingredients": "edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution", "Questions or comments?": "Call 1-800-SHOP-CVS", "Active ingredient (in each softgel)": "Dextromethorphan HBr, USP 15 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information