Gericare Tussindmmax 591

Gericare Tussindmmax 591
SPL v1
SPL
SPL Set ID 47451cd8-7aab-90e2-e063-6394a90ad1b7
Route
ORAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Sucrose Hydroxyethyl Cellulose, Unspecified Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

In each 20 mL Dextromethorphan HBr- 20 mg Guaifenesin - 400 mg


Medication Information

Warnings and Precautions

Warnings

Do not useif you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.

Do not useif you have ever had an allergic reaction to any of the ingredients in this product.

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

Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or head that lasts. These could be signs of a serious condition.

Indications and Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
Dosage and Administration

Directions:

  • do not use more than directed
  • do not take more than 6 doses in 24 hours
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=mililiter
Age Dose
Adults and children over 12 years and over 20 mL every 4 hours
Children under 12 years do not use

Description

In each 20 mL Dextromethorphan HBr- 20 mg Guaifenesin - 400 mg

Section 43683-2

fix typos

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Cente right away.

Section 51727-6

Inactive ingredients artificial and natural flavor, citric acid, FD&C Blue #1, FD&C #40, hydroxyethyl cellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

Section 51945-4

Section 53413-1

Questions or comments?1-866-540-3765

Section 53414-9

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

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

In each 20 mL

Dextromethorphan HBr- 20 mg

Guaifenesin - 400 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
Dosage and Administration (34068-7)

Directions:

  • do not use more than directed
  • do not take more than 6 doses in 24 hours
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=mililiter
Age Dose
Adults and children over 12 years and over 20 mL every 4 hours
Children under 12 years do not use

Warnings and Precautions (34071-1)

Warnings

Do not useif you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.

Do not useif you have ever had an allergic reaction to any of the ingredients in this product.

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

Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or head that lasts. These could be signs of a serious condition.

Section 43683-2 (43683-2)

fix typos

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Cente right away.

Section 51727-6 (51727-6)

Inactive ingredients artificial and natural flavor, citric acid, FD&C Blue #1, FD&C #40, hydroxyethyl cellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-866-540-3765

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

In each 20 mL

Dextromethorphan HBr- 20 mg

Guaifenesin - 400 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)