Llorens-tusnelex 507

Llorens-tusnelex 507
SPL v8
SPL
SPL Set ID 7f703c9c-2256-4524-9d31-c51919399d26
Route
ORAL
Published
Effective Date 2026-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Methylparaben Propylene Glycol Propylparaben Water Trisodium Citrate Dihydrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-01

Description

In each 5 mL Guaifenesin - 100 mg

How Supplied

Product: 50090-6542 NDC: 50090-6542-0 118 mL in a BOTTLE


Medication Information

Warnings and Precautions

Warnings

Do not use if 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.

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 if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Indications and Usage

Uses

  • temporarily relieves cough due to minor thraot and bronchial irritations as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Dosage and Administration

Directions: Do not exceed more than 6 doses in any 24-hour period.

 Age  Dose
 Adults and children over 12 years and over  2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years  Ask a doctor

How Supplied

Product: 50090-6542

NDC: 50090-6542-0 118 mL in a BOTTLE

Description

In each 5 mL Guaifenesin - 100 mg

Section 50565-1

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

Section 51727-6

Inactive ingredients anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate digydrate, and a sucralose.

Section 53413-1

Questions or comments? 1-8660595-5598

Section 53414-9

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

Section 55105-1

Purpose

Expectorant

Section 55106-9

In each 5 mL

Guaifenesin - 100 mg

Guaifenesin Liquid

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough due to minor thraot and bronchial irritations as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Dosage and Administration (34068-7)

Directions: Do not exceed more than 6 doses in any 24-hour period.

 Age  Dose
 Adults and children over 12 years and over  2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years  Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use if 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.

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 if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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.

Section 51727-6 (51727-6)

Inactive ingredients anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate digydrate, and a sucralose.

Section 53413-1 (53413-1)

Questions or comments? 1-8660595-5598

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

In each 5 mL

Guaifenesin - 100 mg

How Supplied (HOW SUPPLIED)

Product: 50090-6542

NDC: 50090-6542-0 118 mL in a BOTTLE

Guaifenesin Liquid (guaifenesin liquid)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)