MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH- acetaminophen, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit

Mucinex Sinus-Max Day Night by

Drug Labeling and Warnings

Mucinex Sinus-Max Day Night 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 SINUS-MAX Day	Purpose
Acetaminophen 325 mg	Pain reliever
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant
Active ingredients (in each caplet) Mucinex SINUS-MAX Night	Purpose
Acetaminophen 325 mg	Pain reliever
Diphenhydramine HCl 25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses
- temporarily relieves:
  - nasal congestion
  - headache
  - minor aches and pains
  - sinus congestion and pressure
  - runny nose and sneezing (Mucinex SINUS-MAX Night only)
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex SINUS-MAX Day only)
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
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 SINUS-MAX Night 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 (Mucinex SINUS-MAX Night only)
- a breathing problem such as emphysema or chronic bronchitis (Mucinex SINUS-MAX Night only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema (Mucinex SINUS-MAX Day only)
- cough that occurs with too much phlegm (mucus) (Mucinex SINUS-MAX Day only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Mucinex SINUS-MAX Night only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (Mucinex SINUS-MAX Night only)
- marked drowsiness may occur (Mucinex SINUS-MAX Night only)
- alcohol, sedatives and tranquilizers may increase drowsiness (Mucinex SINUS-MAX Night only)
- avoid alcoholic drinks (Mucinex SINUS-MAX Night only)
- be careful when driving a motor vehicle or operating machinery (Mucinex SINUS-MAX Night only)
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- pain or nasal congestion 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 persistent headache. These could be signs of a serious condition. (Mucinex SINUS-MAX Day 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 (1-800-222-1222). 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 and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other information
- store at 20-25°C (68-77°F)
Inactive ingredients (Mucinex SINUS-MAX Day)

croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide
Inactive ingredients (Mucinex SINUS-MAX Night)

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 SINUS-MAX Day)
PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

MAXIMUM STRENGTH*

NDC: 63824-202-20

NEW

Mucinex®
SINUS-MAX™

Day

Acetaminophen - Pain Reliever Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

10
CAPLETS

✓ Relieves Sinus Pressure,
Headache & Congestion

✓ Thins & Loosens Mucus

For Ages 12+

Night

Acetaminophen - Pain Reliever Diphenhydramine HCl - Antihistamine
Phenylephrine HCl - Nasal Decongestant

✓ Relieves Nasal Congestion,
Sinus Pressure & Pain

✓ Relieves Runny Nose
& Sneezing

10
CAPLETS

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

INGREDIENTS AND APPEARANCE

MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH
acetaminophen, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-202

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63824-202-20	1 in 1 CARTON

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	2 BLISTER PACK	10
Part 2	2 BLISTER PACK	10

Part 1 of 2

MUCINEX SINUS-MAX DAY MAXIMUM STRENGTH
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet

Product Information
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
croscarmellose sodium (UNII: M28OL1HH48)
crospovidone (UNII: 68401960MK)
FD&C red no. 40 (UNII: WZB9127XOA)
FD&C yellow no. 6 (UNII: H77VEI93A8)
aluminum oxide (UNII: LMI26O6933)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
polyethylene glycols (UNII: 3WJQ0SDW1A)
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;CS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/10/2012

Part 2 of 2

MUCINEX SINUS-MAX NIGHT MAXIMUM STRENGTH
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
starch, corn (UNII: O8232NY3SJ)
croscarmellose sodium (UNII: M28OL1HH48)
crospovidone (UNII: 68401960MK)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
hypromelloses (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
polydextrose (UNII: VH2XOU12IE)
polyethylene glycols (UNII: 3WJQ0SDW1A)
povidones (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/10/2012

Labeler - Reckitt Benckiser LLC (094405024)