Cvs Sugar-free Adult Cough+chest Congestion Dm Drug Facts

Cvs Sugar-free Adult Cough+chest Congestion Dm Drug Facts
SPL v1
SPL
SPL Set ID f6e8f66d-45a3-4b23-a37e-552e972db3f8
Route
ORAL
Published
Effective Date 2023-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Potassium Citrate Propylene Glycol Water Sodium Benzoate Glycerin Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-07-10

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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 drain bronchial tubes
Purpose

Cough suppressant Expectorant

Dosage and Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

20 ml every 4 hours

children under 12 years

do not use

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Section 44425-7

Other information

  • each 20 ml contains: sodium 7 mg
  • store at room temperature. Do not refrigerate.
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50566-9

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1

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.

Section 51727-6

Inactive ingredients

anhydrous citric acid, disodium edetate, FD&C Red No 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Section 53413-1

Questions or comments?

1-866-467-2748

Section 53414-9

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

Purposes

Cough suppressant

Expectorant

Principal Display Panel

Compare to the active ingredients in Adult Robitussin® Sugar-Free Cough + Chest Congestion DM*

NDC 51316-749-08



SUGAR-FREE

Adult

Cough+Chest

Congestion DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus



Specially

Formulated

for DIABETICS

For Ages 12 & Over

8 FL OZ (237 ml)

Distributed by:

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Adult Robitussin® Sugar-Free Cough+Chest Congestion DM.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg


Structured Label Content

Indications and Usage (34067-9)

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 drain bronchial tubes
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

20 ml every 4 hours

children under 12 years

do not use

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • each 20 ml contains: sodium 7 mg
  • store at room temperature. Do not refrigerate.
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 at 1-800-222-1222.

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, disodium edetate, FD&C Red No 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Section 53413-1 (53413-1)

Questions or comments?

1-866-467-2748

Section 53414-9 (53414-9)

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

Purposes

Cough suppressant

Expectorant

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredients in Adult Robitussin® Sugar-Free Cough + Chest Congestion DM*

NDC 51316-749-08



SUGAR-FREE

Adult

Cough+Chest

Congestion DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus



Specially

Formulated

for DIABETICS

For Ages 12 & Over

8 FL OZ (237 ml)

Distributed by:

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Adult Robitussin® Sugar-Free Cough+Chest Congestion DM.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 ml))

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg


Advanced Ingredient Data


Raw Label Data

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