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 RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
Mucinex FAST-MAX DAY TIME Severe Cold
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)	Purposes
Mucinex FAST-MAX NIGHT TIME Cold & Flu
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough (Mucinex FAST-MAX DAY TIME Severe Cold only)
  • minor aches and pains
  • headache
  • sore throat
  • runny nose and sneezing (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex FAST-MAX DAY TIME Severe Cold 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 that contain acetaminophen
• 3 or more alcoholic drinks daily while using this product

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 (Mucinex FAST-MAX NIGHT TIME Cold & Flu 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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
• a breathing problem such as emphysema or chronic bronchitis (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Mucinex FAST-MAX DAY TIME Severe Cold only)
• cough that occurs with too much phlegm (mucus) (Mucinex FAST-MAX DAY TIME Severe Cold only)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)

When using this product

• do not use more than directed
• excitability may occur, especially in children (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
• marked drowsiness may occur (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
• avoid alcoholic drinks (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
• be careful when driving a motor vehicle or operating machinery (Mucinex FAST-MAX NIGHT TIME Cold & Flu 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 fever, rash, or headache that lasts. These could be a sign of a serious condition. (Mucinex FAST-MAX DAY TIME Severe Cold only)

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 #40 aluminum lake, FD&C Yellow #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)

corn starch, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

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 (Mucinex FAST-MAX DAY TIME Severe Cold)

PRINCIPAL DISPLAY PANEL - Kit Carton

MAXIMUM STRENGTH*

DAY TIME
NIGHT TIME

MAXIMUM STRENGTH*

NDC: 63824-551-30

Mucinex®

FAST-MAX®

DAY
TIME

Severe Cold

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

NEW!

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

AGES 12+

20 CAPLETS

 

NIGHT
TIME

Cold & Flu

Acetaminophen Pain Reliever/Fever Reducer
Diphenhydramine HCl Antihistamine
Phenylephrine HCl Nasal Decongestant

✓ Relieves Aches,
Fever & Sore Throat
✓ Relieves Nasal Congestion
✓ Relieves Runny Nose
& Sneezing

10 CAPLETS

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: 63824-551

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-551-30	1 in 1 CARTON	05/01/2013

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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	05/01/2013

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	25 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 (15 MPA.S AT 5%) (UNII: 68401960MK)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
polydextrose (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
silicon dioxide (UNII: ETJ7Z6XBU4)
stearic acid (UNII: 4ELV7Z65AP)
titanium dioxide (UNII: 15FIX9V2JP)
triacetin (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	44;544
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	05/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/01/2013

Labeler - RB Health (US) LLC (081049410)