Label: MAXIMUM STRENGTH MUCINEX FAST-MAX DAY TIME COLD AND FLU AND NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 63824-511-10, 63824-511-20, 63824-511-40 - Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 October 27, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients (in each caplet) Purposes Mucinex FAST-MAX DAY TIME COLD & FLU Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant Active ingredients (in each caplet) Purposes Mucinex FAST-MAX NIGHT TIME COLD & FLU Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant -
Uses
Mucinex Fast-Max DAY TIME COLD & FLU
- temporarily relieves these common cold and flu symptoms:
- cough
- minor aches and pains
- headache
- nasal congestion
- sore throat
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- controls cough to help you get to sleep
- temporarily reduces fever
Mucinex Fast-Max NIGHT TIME COLD & FLU
- temporarily relieves these common cold and flu symptoms:
- cough
- minor aches and pains
- headache
- nasal congestion
- sore throat
- sinus congestion and pressure
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- controls cough to help you get to sleep
- temporarily reduces fever
- 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.
- with any other product containing diphenhydramine, even one used on the skin (NIGHT TIME only)
- 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
- glaucoma (NIGHT TIME only)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (NIGHT TIME only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (NIGHT TIME only)
- marked drowsiness may occur (NIGHT TIME only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
- avoid alcoholic drinks (NIGHT TIME only)
- be careful when driving a motor vehicle or operating machinery (NIGHT TIME only)
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
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Inactive ingredients
(Mucinex FAST-MAX NIGHT TIME COLD & FLU)
croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 63824-511-40
MAXIMUM STRENGTH
Mucinex®
FAST-MAX®DAY
TIME
COLD & FLUAcetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal DecongestantHEADACHE
BODY PAIN
SORE THROAT
FEVER
CHEST CONGESTION
COUGH
ALL IN
ONE*
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSUREActual Size
FOR AGES 12+
24 CAPLETS
NIGHT
TIME
COLD & FLUAcetaminophen – Pain Reliever/Fever Reducer
Diphenhydramine HCl – Antihistamine/
Cough Suppressant
Phenylephrine HCl – Nasal DecongestantHEADACHE
BODY PAIN
SORE THROAT
FEVER
ITCHY THROAT
COUGH
ALL IN
ONE*
NASAL CONGESTION
SNEEZING
RUNNY NOSEActual Size
FOR AGES 12+
16 CAPLETS
TOTAL 40 CAPLETS
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH MUCINEX FAST-MAX DAY TIME COLD AND FLU AND NIGHT TIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-511 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-511-10 1 in 1 CARTON 06/01/2020 2 NDC:63824-511-20 2 in 1 CARTON 06/01/2020 2 1 in 1 KIT 3 NDC:63824-511-40 4 in 1 CARTON 06/01/2020 3 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 6 Part 2 1 BLISTER PACK 4 Part 1 of 2 MAXIMUM STRENGTH MUCINEX FAST-MAX DAY TIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tabletProduct Information 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 Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength croscarmellose sodium (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C red no. 40 (UNII: WZB9127XOA) FD&C yellow no. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) Magnesium stearate (UNII: 70097M6I30) microcrystalline cellulose (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape OVAL Size 20mm Flavor Imprint Code VVV;MSC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 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 06/01/2020 Part 2 of 2 MAXIMUM STRENGTH MUCINEX FAST-MAX NIGHT TIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 12.5 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength croscarmellose sodium (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C blue no. 1 (UNII: H3R47K3TBD) FD&C blue no. 2 (UNII: L06K8R7DQK) ALUMINUM OXIDE (UNII: LMI26O6933) ferric oxide yellow (UNII: EX438O2MRT) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) mica (UNII: V8A1AW0880) microcrystalline cellulose (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) sodium bicarbonate (UNII: 8MDF5V39QO) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL Size 20mm Flavor Imprint Code VVV;CF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2020 Labeler - RB Health (US) LLC (081049410)