Reliable-1 Tussin Liquid
FDA Label NDC 69618-068

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Reliable-1 Tussin (NDC 69618-068). 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 10 mL

Guaifenesin - 200 mg

Otc - Purpose

Purpose

Expectorant

Indications & Usage

Uses

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

Warnings

Warnings

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a 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 accompnaied 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 tha 6 doses in any 24 hour period
  • Measure only with dosing cup provided
  • mL- mililiters
  • Adults and children over 12 years of age: take 2 teaspoonfuls (10 mL) every 4 hours as needed or as directed by a doctor
  • Children under 12 years of age: Do not use

Inactive Ingredient

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

Otc - Questions

Questions or comments? 1-516-341-0666 8:30 am - 4:30 pm EST Mon-Fri

Package Label.Principal Display Panel

Tussin (Tussin)

Tussin (Tussin)

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