MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH CLEAR AND COOL AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU CLEAR AND COOL- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride 
RB Health (US) LLC

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.

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Mucinex® Fast-Max® Severe Congestion & Cough Clear & Cool and Mucinex® Fast-Max® Night Time Cold & Flu Clear & Cool

Drug Facts

Active ingredients (in each 20 mL)
Mucinex FAST-MAX Severe Congestion & Cough CLEAR & COOL
Purposes
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant

Active ingredients (in each 20 mL)
Mucinex FAST-MAX NIGHT TIME Cold & Flu CLEAR & COOL
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine HCl 25 mg Antihistamine/cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant

Uses

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

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 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.

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)
  • breathing problems 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 rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

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.

Directions

Other information

Inactive ingredients (Mucinex FAST-MAX Severe Congestion & Cough CLEAR & COOL)

anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Inactive ingredients (Mucinex FAST-MAX NIGHT TIME Cold & Flu CLEAR & COOL)

anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

Questions?

1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 63824-541-66

MAXIMUM STRENGTH

Mucinex®
FAST-
MAX®

SEVERE CONGESTION
& COUGH

CLEAR & COOL

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

✓ Controls Cough
✓ Relieves Nasal & Chest Congestion
✓ Thins & Loosens Mucus

6 FL OZ (180mL)
FOR AGES 12+

NDC 63824-510-66

MAXIMUM STRENGTH*

Mucinex®
FAST-
MAX®

NIGHT TIME
COLD & FLU

CLEAR & COOL

Acetaminophen – 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

6 FL OZ (180mL)
FOR AGES 12+

PRINCIPAL DISPLAY PANEL - Kit Carton
MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH CLEAR AND COOL AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU CLEAR AND COOL 
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-544
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-544-22 1 in 1 CARTON 07/01/2016
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 CLEAR AND COOL
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Item Code (Source) NDC:63824-541
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)  
D&C yellow no. 10 (UNII: 35SW5USQ3G)  
edetate disodium (UNII: 7FLD91C86K)  
Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
glycerin (UNII: PDC6A3C0OX)  
propyl gallate (UNII: 8D4SNN7V92)  
propylene glycol (UNII: 6DC9Q167V3)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
Color GREEN Score     
Shape Size
Flavor MENTHOL Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-541-66 180 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 07/01/2016
Part 2 of 2
MUCINEX FAST-MAX   NIGHT TIME COLD AND FLU CLEAR AND COOL
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
Product Information
Item Code (Source) NDC:63824-510
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)  
D&C yellow no. 10 (UNII: 35SW5USQ3G)  
edetate disodium (UNII: 7FLD91C86K)  
Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
glycerin (UNII: PDC6A3C0OX)  
propyl gallate (UNII: 8D4SNN7V92)  
propylene glycol (UNII: 6DC9Q167V3)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
Color GREEN Score     
Shape Size
Flavor MENTHOL Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-510-66 180 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 07/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/01/2016
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2018
Document Id: ca582994-7b9f-4e65-9ffe-fd62576b4a22
Set id: 2723db81-b382-4ee1-9e33-bb7c84e598af
Version: 2
Effective Time: 20181211
 
RB Health (US) LLC