Quality Choice®

Quality Choice®
SPL v1
SPL
SPL Set ID f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c
Route
ORAL
Published
Effective Date 2024-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Type B Bovine (230 Bloom) 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 2024-08-16

Description

Dextromethorphan HBr, USP 15 mg

Purpose

Cough Suppressant


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®*

Adult

Relieves cough for up to 8 Hours

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  

QC 100% SATISFACTION GUARANTEED ®

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

PRODUCT OF UNITED ARAB EMIRATES

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, 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 can 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 older
 take 2 softgels every

 6 to 8 hours,

 as needed
 children under

 12 years
 do not use

Drug Facts

Active Ingredient

Dextromethorphan HBr, USP 15 mg

Other Information

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

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

• protect from light, heat and moisture

Inactive Ingredients

edible white ink, FD&C blue no.1, FD&C red no. 40, gelatin (bovine), glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-888-577-8033 Monday - Friday

8am - 4pm EST


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®*

Adult

Relieves cough for up to 8 Hours

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  

QC 100% SATISFACTION GUARANTEED ®

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

PRODUCT OF UNITED ARAB EMIRATES

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, 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 can 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 older
 take 2 softgels every

 6 to 8 hours,

 as needed
 children under

 12 years
 do not use

Drug Facts

Active Ingredient (Active ingredient)

Dextromethorphan HBr, USP 15 mg

Other Information (Other information)

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

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

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

edible white ink, FD&C blue no.1, FD&C red no. 40, gelatin (bovine), glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday

8am - 4pm EST


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)