MUCINEX FAST-MAX DAY TIME SEVERE COLD 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 Cold and Mucinex Fast-Max Night Time Cold and Flu by

Drug Labeling and Warnings

Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet) Mucinex FAST-MAX DAY TIME Severe Cold	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

ACTIVE INGREDIENT

Active ingredients (in each caplet) Mucinex FAST-MAX NIGHT TIME Cold & Flu	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • runny nose (NIGHT TIME only)
  • sneezing (NIGHT TIME only)
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
• controls cough to help you get to sleep (NIGHT TIME only)
• temporarily reduces fever

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 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
• 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
• 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 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 12 caplets in any 24-hour period
• adults and children 12 years of age and older: take 2 caplets every 4 hours
• children under 12 years of age: do not use

Other information

• store between 20-25°C (68-77°F)

Inactive ingredients (Mucinex FAST-MAX DAY TIME Severe Cold)

croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, povidone, talc, titanium dioxide

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

croscarmellose sodium, crospovidone, FD&C blue no. 1, FD&C blue no. 2, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycols, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

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
Made in England

PRINCIPAL DISPLAY PANEL - Kit Carton

MAXIMUM STRENGTH*

NDC: 63824-557-30

Mucinex®

FAST-MAX®

DAY
TIME
SEVERE COLD

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

• ✓ Relieves Aches, Fever
  & Sore Throat
• ✓ Controls Cough
• ✓ Relieves Nasal & Chest
  Congestion
• ✓ Thins & Loosens Mucus

20 CAPLETS

NIGHT
TIME
COLD & FLU

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

10 CAPLETS

FOR AGES 12+

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-557

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-557-30	1 in 1 CARTON

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 DAY TIME SEVERE COLD   MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
croscarmellose sodium (UNII: M28OL1HH48)
crospovidone (15 MPA.S at 5%) (UNII: 68401960MK)
FD&C red no. 40 (UNII: WZB9127XOA)
aluminum oxide (UNII: LMI26O6933)
FD&C yellow no. 6 (UNII: H77VEI93A8)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
polyvinyl alcohol (UNII: 532B59J990)
povidones (UNII: FZ989GH94E)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	VVV;MCS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		10 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	08/25/2015

Part 2 of 2

MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated

Product 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 (15 MPA.S at 5%) (UNII: 68401960MK)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C blue no. 2 (UNII: L06K8R7DQK)
ferric oxide yellow (UNII: EX438O2MRT)
methacrylic acid - ethyl acrylate copolymer (1:1) type a (UNII: NX76LV5T8J)
mica (UNII: V8A1AW0880)
cellulose, microcrystalline (UNII: OP1R32D61U)
polyethylene glycols (UNII: 3WJQ0SDW1A)
polyvinyl alcohol (UNII: 532B59J990)
povidone k29/32 (UNII: 390RMW2PEQ)
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;SI
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		10 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	08/25/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/25/2015

Labeler - Reckitt Benckiser LLC (094405024)