MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu by
Drug Labeling and Warnings
Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients (in each 20 mL)
Mucinex FAST-MAX Day Time Severe Congestion & CoughPurposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant Active ingredients (in each 20 mL) Purposes Mucinex FAST-MAX Night Time Cold & Flu Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/cough suppressant Phenylephrine HCl 10 mg Nasal decongestant -
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
- the impulse to cough to help you get to sleep
- 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)
- nasal congestion
- minor aches and pains
- headache
- cough
- sore throat
- runny nose and sneezing
- temporarily reduces fever (Night Time only)
- controls cough to help you get to sleep
- temporarily relieves (Day Time only):
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Warnings
Liver warning (Night Time only)
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
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 drug 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease (Night Time only)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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.
In addition, for Night Time only:
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
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.
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Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients (Day Time)
- Inactive ingredients (Night Time)
- Questions?
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PRINCIPAL DISPLAY PANEL - Kit Carton
NDC: 63824-528-22
MAXIMUM STRENGTH*
Mucinex®
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
Mucinex®
FAST-MAX®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
*per 4 hour dose.
AGE 12+ TWO – 6 fl oz (180 mL) bottles TOTAL – 12 fl oz (360 mL) AGE 12+
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INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 63824-528 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 63824-528-22 1 in 1 CARTON 05/09/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 180 mL Part 2 1 BOTTLE 180 mL Part 1 of 2 MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Item Code (Source) NDC: 63824-014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 20 mg in 20 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg in 20 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) edetate disodium (UNII: 7FLD91C86K) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Red No. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) propyl gallate (UNII: 8D4SNN7V92) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) trisodium citrate dihydrate (UNII: B22547B95K) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 63824-014-66 180 mL in 1 BOTTLE; 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 02/07/2012 Part 2 of 2 MAXIMUM STRENGTH MUCINEX FAST-MAX NIGHT TIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solutionProduct Information Item Code (Source) NDC: 63824-500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 650 mg in 20 mL Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg in 20 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) edetate disodium (UNII: 7FLD91C86K) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Red No. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) propyl gallate (UNII: 8D4SNN7V92) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) trisodium citrate dihydrate (UNII: B22547B95K) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 63824-500-66 180 mL in 1 BOTTLE; 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 03/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/09/2014 Labeler - RB Health (US) LLC (081049410)
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