qc® 

qc® 
SPL v3
SPL
SPL Set ID 9a31b331-fbd3-42de-836b-1c3bb305419b
Route
oral
Published
Effective Date 2022-09-13
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, 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 2022-05-03

Purpose

Cough Suppressant

Description

Dextromethorphan HBr, USP 15 mg


Medication Information

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.

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

 adults and children

 12 years and older

take 2 softgels every

6 to 8 hours, as

 needed

 children under

 12 years

do not use

Other Information

• store at 20°-25°C(68°-77°F)

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

• protect from light

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

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®*

Relieves cough for up to 8 Hours

Non-Drowsy

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Distributed by: C.D.M.A., Inc.©

43157 W 9 Mile Rd Novi, MI 48375

www.qualitychoice.com

Product of UAE

Packaged and Quality Assured in the USA

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

100% QC SATISFACTION GUARANTEED

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.

Packaging

Drug Facts

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 15 mg


Structured Label Content

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.

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

 adults and children

 12 years and older

take 2 softgels every

6 to 8 hours, as

 needed

 children under

 12 years

do not use

Other Information (Other information)

• store at 20°-25°C(68°-77°F)

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

• protect from light

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

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®*

Relieves cough for up to 8 Hours

Non-Drowsy

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Distributed by: C.D.M.A., Inc.©

43157 W 9 Mile Rd Novi, MI 48375

www.qualitychoice.com

Product of UAE

Packaged and Quality Assured in the USA

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

100% QC SATISFACTION GUARANTEED

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.

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST

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

Dextromethorphan HBr, USP 15 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)