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Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
©2025 RB Health
Mucinex Cold, Flu, And Sore Throat Capsule, Liquid Filled
FDA Label NDC 72854-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Cold, Flu, And Sore Throat (NDC 72854-164). 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 other, otc - active ingredient, uses, warnings, directions, recent major changes, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Acetaminophen 325 mg.............Pain reliever/fever reducer
Guaifenesin 200 mg...............................................Expectorant
Uses
Uses
■ temporarily relieves these common cold and flu symptoms:
■ minor aches and pains
■ headache ■ sore throat
■ helps loosen phlegm (mucus) and thin bronchial secretions
to rid the bronchial passageways of bothersome mucus
and make coughs more productive
■ temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
■ more than 12 liquid gels in 24 hours, which is the
maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right
away.
Sore throat warning: If sore throat is severe, persists for
more than 2 days, is accompanied or followed by fever,
headache, rash, nausea, or vomiting, consult a doctor
promptly.
Directions
■ do not take more than directed (see Overdose warning)
■ do not take more than 12 liquid gels in any 24-hour period
■ adults and children 12 years of age and over: take
2 liquid gels every 4 hours
■ children under 12 years of age: do not use
Recent Major Changes
■ do not take more than directed (see Overdose warning)
■ do not take more than 12 liquid gels in any 24-hour period
■ adults and children 12 years of age and over: take
2 liquid gels every 4 hours
■ children under 12 years of age: do not use
Other Information
■ store at 20-25°C (68-77°F)
■ avoid excessive heat
Inactive Ingredients
FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light
mineral oil, polyethylene glycol, povidone, propylene glycol,
purified water, sorbitol sorbitan solution, titanium dioxide
Questions?
1-866-MUCINEX (1-866-682-4639)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Principal Display Panel
Fast Dissolving Liquid Gels!
NDC 72854-164
Mucinex®
COLD, FLU, and SORE THROAT
Acetaminophen – Pain Reliever/Fever Reducer
Guaifenesin – Expectorant
✓Thins & Loosens Mucus
✓Relieves Sore Throat, Headache, and Body Pain
✓Reduces Fever
LIQUID GELS
(Liquid Filled Capsules)
Actual Size
DAY TIME
FOR AGES 12+
* Please review the disclaimer below.
