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

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

Drug Labeling and Warnings

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

Drug Facts

ACTIVE INGREDIENT

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 INGREDIENT

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

• 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 (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
• temporarily helps you cough less
• temporarily relieves these common cold and flu symptoms (NIGHT TIME only):
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
• temporarily reduces fever (NIGHT TIME only)
• controls cough to help you get to sleep (NIGHT TIME only)

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

• 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
• adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
• children under 12 years of age: do not use

Other information

• each 20 mL contains: sodium 9 mg
• store between 20-25°C (68-77°F)
• dosing cup provided
• do not refrigerate

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.

SPL UNCLASSIFIED SECTION

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+

INGREDIENTS AND APPEARANCE

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)