Long Acting Cough Softgels

Long Acting Cough Softgels
SPL v4
SPL
SPL Set ID 322daee6-c61d-43d3-a54d-a354fd3df242
Route
ORAL
Published
Effective Date 2021-10-27
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 2021-07-28

Description

Dextromethorphan HBr, USP 15mg

Purpose

Cough Suppressant


Medication Information

Purpose

Cough Suppressant

Description

Dextromethorphan HBr, USP 15mg

Use

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

Section 42229-5

CVS Health®

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

Non-Drowsy

Controls cough

8 HOUR

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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Product of UAE

V-38084

CVS ® Quality

Money Back Guarantee

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

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

Questions Or Comments?

1-888-577-8033 Monday-Friday

8am-4pm EST

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 15mg


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)

CVS Health®

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

Non-Drowsy

Controls cough

8 HOUR

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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Product of UAE

V-38084

CVS ® Quality

Money Back Guarantee

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

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

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 15mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)