Label: MUCINEX FAST-MAX COLD AND FLU- acetaminophen, guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet, film coated
- NDC Code(s): 63824-514-01
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 27, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these common cold and flu symptoms:
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 caplets 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.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
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Directions
- 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 over: take 2 caplets every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
NDC 63824-514-01
MAXIMUM STRENGTH
Mucinex®
FAST-MAX®COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCl – Nasal DecongestantHEADACHE
BODY PAINSORE THROAT
FEVERCHEST CONGESTION
COUGHALL IN
ONE*NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE
20 CAPLETS
FOR AGES 12+
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INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX COLD AND FLU
acetaminophen, guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-514 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) FD&C red no. 40 (UNII: WZB9127XOA) Aluminum oxide (UNII: LMI26O6933) FD&C yellow no. 6 (UNII: H77VEI93A8) magnesium stearate (UNII: 70097M6I30) maltodextrin (UNII: 7CVR7L4A2D) microcrystalline cellulose (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) silicon dioxide (UNII: ETJ7Z6XBU4) sodium starch glycolate type a potato (UNII: 5856J3G2A2) stearic acid (UNII: 4ELV7Z65AP) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape OVAL Size 19mm Flavor Imprint Code DCH Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-514-01 2 in 1 CARTON 08/01/2018 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/01/2018 Labeler - RB Health (US) LLC (081049410)