temporarily relieves these common cold and flu symptoms: nasal congestion cough minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
do not take more than directed (see Overdose warning ) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and older: take 2 caplets every 4 hours children under 12 years of age: do not use
store at 20-25°C (68-77°F)
Drug Facts
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
temporarily relieves these common cold and flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin
When using this product do not use more than directed
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
corn starch, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
MAXIMUM STRENGTH
NDC 63824-517-01
Mucinex®
FAST-MAX
®
COLD, FLU
& SORE THROAT
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
20 CAPLETS
FOR AGES 12+
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-517 | MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [RB HEALTH (US) LLC] | 4 | Legacy NDC | 20231003_492b48ce-2d03-45b4-9af6-c3dd315b74f8.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63824-517 | 63824-517-01 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 06c28dcc-bea8-ebdd-e063-6394a90a6c91 | 492b48ce-2d03-45b4-9af6-c3dd315b74f8 | 2023-10-02 | Warnings | 06c28dcc-bea8-ebdd-e063-6394a90a6c91 492b48ce-2d03-45b4-9af6-c3dd315b74f8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.