Cvs Health®

Cvs Health®
SPL v2
SPL
SPL Set ID 2741ba44-1cc7-1812-e063-6394a90a8faa
Route
ORAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Fd&c Red No. 40 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-15

Description

Dextromethorphan hydrobromide 10 mg Guaifenesin 200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan hydrobromide 10 mg Guaifenesin 200 mg

Uses

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

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5

Compare to the active ingredients in Coricidin® HBP Chest Congestion & Cough*

Decongestant Free

For People with High Blood Pressure

Relieves:

• Chest congestion

• Cough

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Coricidin® HBP Chest Congestion and Cough.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com®

Product of India

100% money back guaranteed.

CVS.com/returnpolicy

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury.

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 • if you have ever had an allergic reaction to this product or any of its ingredients • in children under 12 years of age

Ask a doctor before use if you have

• cough that occurs with excessive phlegm (mucus)

• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with 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 exceed recommended dose

• adults and children 12 years and over: 1 or 2 softgels every 4 hours. Do not take more than 12 softgels in 24 hours or as directed by a doctor

• children under 12 years of age: do not use

Drug Facts

Other Information

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

• avoid excessive heat above 40°C (104°F) • protect from excessive moisture

Inactive Ingredients

FD&C Red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

Call 1-800-SHOP-CVS

Active Ingredients (in Each Softgel)

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg


Structured Label Content

Uses

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

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5 (42229-5)

Compare to the active ingredients in Coricidin® HBP Chest Congestion & Cough*

Decongestant Free

For People with High Blood Pressure

Relieves:

• Chest congestion

• Cough

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Coricidin® HBP Chest Congestion and Cough.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com®

Product of India

100% money back guaranteed.

CVS.com/returnpolicy

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury.

Purpose

Cough suppressant

Expectorant

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 • if you have ever had an allergic reaction to this product or any of its ingredients • in children under 12 years of age

Ask a doctor before use if you have

• cough that occurs with excessive phlegm (mucus)

• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with 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 exceed recommended dose

• adults and children 12 years and over: 1 or 2 softgels every 4 hours. Do not take more than 12 softgels in 24 hours or as directed by a doctor

• children under 12 years of age: do not use

Drug Facts

Other Information (Other information)

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

• avoid excessive heat above 40°C (104°F) • protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

FD&C Red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-SHOP-CVS

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg


Advanced Ingredient Data


Raw Label Data

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