Leader Adult Tussin Mucus And Chest Congestion 541 Liquid
FDA Label NDC 70000-0696

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Adult Tussin Mucus And Chest Congestion 541 (NDC 70000-0696). 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 active ingredient(s), purpose, use(s), warnings, ask a doctor before use if you have, stop use and ask doctor if, if pregnant or breast-feeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Stop Use And Ask Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingradients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient(S)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Use(S)

helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

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 Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

shake well before using

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 & children 12 years & over	10 mL to 20 mL every 4 hours
children under 12 years	ask a doctor

Other Information

each 10 mL contains: sodium 12 mg
store at 20-25^oC(68-77^oF)
protect from light

Inactive Ingradients

caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate.