Active Ingredient (In Each Extended-Release Tablet)
Guaifenesin 1200 mg
Leader Mucus Relief Tablet, Multilayer, Extended Release
FDA Label NDC 70000-0721
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 Mucus Relief (NDC 70000-0721). 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 (in each extended-release tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a 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
Purpose
Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Do Not Use
- for children under 12 years of age
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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 (1-800-222-1222).
Directions
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for timing of meals
- adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
Other Information
- store at 20-25°C (68-77°F)
Inactive Ingredients
carbomer homopolymer type B, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
LEADER™
Maximum Strength
Mucus Relief
Guaifenesin Extended-Release Tablets, 1200 mg
Expectorant
12-Hour
Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release
Actual Size
COMPARE TO MAXIMUM STRENGTH MUCINEX® active ingredient
14 EXTENDED-RELEASE TABLETS
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Mucus-relief-carton (4s174e9c1)
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