Llorens Care Tussin Liquid
FDA Label NDC 54859-510

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division, Inc. for the product Llorens Care Tussin (NDC 54859-510). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

In each 5 mL teaspoonful

Guaifenesin - 100 mg

Otc - Purpose

Purpose

Expectorant

Indications & Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Warnings

Do not use

  • if you 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 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

  • do not take more than 6 doses in a 24 hour period
  • do not exceed recommended dose
    • adults and children 12 years and over 2 teaspoonfuls (10 mL) every 4 hours as needed or as directed by a doctor
    children under 12 yearsdo not use

Inactive Ingredient

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Otc - Questions

Questions or comments? 1-866-595-5598

Package Label.Principal Display Panel

Lctussin510 (Lctussin510)

Lctussin510 (Lctussin510)

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