Label: MUCINEX FAST MAX DAY TIME SEVERE CONGESTION AND COUGH AND NIGHT TIME COLD AND FLU- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide, acetaminophen, and diphenhydrmaine hydrochloride kit
- NDC Code(s): 63824-515-01, 63824-792-01
- 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 September 27, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves
(DAY TIME only):
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- nasal congestion due to a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
- temporarily relieves these common cold and flu symptoms
(NIGHT TIME only):
- cough
- minor aches and pains
- headache
- nasal congestion
- sore throat
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- temporarily reduces fever (NIGHT TIME only)
- controls cough to help you get to sleep
- temporarily relieves
(DAY TIME only):
-
Warnings
Liver warning (NIGHT TIME only)
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 (NIGHT TIME only)
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 (NIGHT TIME only)
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. (NIGHT TIME only)
- 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 (NIGHT TIME only)
- 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 (NIGHT TIME only)
- 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
- symptoms do not get better within 7 days or occur with fever (DAY TIME only)
- pain, nasal congestion, or cough gets worse or lasts more than 7 days (NIGHT TIME only)
- fever gets worse or lasts more than 3 days (NIGHT TIME only)
- redness or swelling is present (NIGHT TIME only)
- new symptoms occur (NIGHT TIME only)
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
-
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 (Mucinex FAST-MAX DAY TIME SEVERE CONGESTION & COUGH)
-
Inactive ingredients (Mucinex FAST-MAX NIGHT TIME COLD & FLU)
corn starch, croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide
-
PRINCIPAL DISPLAY PANEL - Kit Carton
MAXIMUM STRENGTH
NDC 63824-792-01Mucinex®
FAST-Max ®DAY
TIME
SEVERE CONGESTION
& COUGHDextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant- Controls Cough
- Relieves Nasal & Chest
Congestion - Thins & Loosens Mucus
20 CAPLETS
FOR AGES 12+
NIGHT
TIME
COLD & FLUAcetaminophen - Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/
Cough Suppressant
Phenylephrine HCl - Nasal Decongestant- Relieves Aches, Fever
& Sore Throat - Controls Cough
- Relieves Nasal Congestion
- Relieves Runny Nose
& Sneezing
10 CAPLETS
FOR AGES 12+
TOTAL 30 CAPLETS
-
INGREDIENTS AND APPEARANCE
MUCINEX FAST MAX DAY TIME SEVERE CONGESTION AND COUGH AND NIGHT TIME COLD AND FLU
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide, acetaminophen, and diphenhydrmaine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-792 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-792-01 1 in 1 PACKAGE, COMBINATION 12/15/2018 02/16/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 20 Part 2 1 BLISTER PACK 10 Part 1 of 2 MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH
guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet, film coatedProduct Information Item Code (Source) NDC:63824-515 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) 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 SRS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-515-01 2 in 1 CARTON 1 10 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2018 Part 2 of 2 MUCINEX FAST-MAX NIGHT TIME SEVERE COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, film coatedProduct 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 STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 19mm Flavor Imprint Code MVA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 10 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/15/2018 02/16/2025 Labeler - RB Health (US) LLC (081049410)