MUCINEX SINUS-MAX DAY TIME SEVERE CONGESTION RELIEF AND MUCINEX SINUS-MAX NIGHT TIME CONGESTION AND COUGH MAXIMUM STRENGTH- acetaminophen, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit

Mucinex Sinus-Max Day Time Severe Congestion Relief and Mucinex Sinus-Max Night Time Congestion and Cough by

Drug Labeling and Warnings

Mucinex Sinus-Max Day Time Severe Congestion Relief and Mucinex Sinus-Max Night Time Congestion and Cough 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 SINUS-MAX Day Time	Purposes
Acetaminophen 650 mg	Pain reliever
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

ACTIVE INGREDIENT

Active ingredients (in each 20 mL) SINUS-MAX Night Time	Purposes
Acetaminophen 650 mg	Pain reliever
Diphenhydramine HCl 25 mg	Antihistamine/cough suppressant
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

• temporarily relieves:
  • nasal congestion
  • headache
  • cough (Night Time only)
  • minor aches and pains
  • sinus congestion and pressure
  • controls cough to help you get to sleep (Night Time only)
  • runny nose and sneezing (Night Time only)
• temporarily promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passa geways of bothersome mucus and make coughs more productive (Day Time only)

Warnings

Liver warning

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 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 (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.
• for children under 12 years of age

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)
• a breathing problem 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 fever, 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 an y 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
• mL = milliliter
• 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 12 mg
• do not refrigerate
• store between 20-25°C (68-77°F)
• dosing cup provided

Inactive ingredients (Mucinex SINUS-MAX Day Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1 may contain this ingredient

Inactive ingredients (Mucinex SINUS-MAX Night Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate2, xanthan gum

2 may contain this ingredient

Questions?

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: 63824-263-22

MAXIMUM STRENGTH*

Mucinex®
SINUS-MAX®

DAY TIME

Severe Congestion Relief

Acetaminophen Pain Reliever
Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant

• ✓ Clears Sinus Congestion
• ✓ Relieves Headache
• ✓ Thins & Loosens Mucus

Mucinex®
SINUS-MAX®

NIGHT TIME

Congestion & Cough

Acetaminophen Pain Reliever
Diphenhydramine HCl Antihistamine/Cough Suppressant
Phenylephrine HCl Nasal Decongestant

• ✓ Clears Sinus Congestion
• ✓ Relieves Headache
• ✓ Relieves Runny Nose & Sneezing
• ✓ Controls Cough

AGES 12+
TWO – 6 fl oz (180 mL) bottles TOTAL – 12 fl oz (360 mL)
AGES 12+

INGREDIENTS AND APPEARANCE

MUCINEX SINUS-MAX DAY TIME SEVERE CONGESTION RELIEF AND MUCINEX SINUS-MAX NIGHT TIME CONGESTION AND COUGH  MAXIMUM STRENGTH
acetaminophen, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-263

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-263-22	1 in 1 CARTON	04/28/2014

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 SINUS-MAX   SEVERE CONGESTION RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 63824-261
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
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-261-66	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	03/26/2014

Part 2 of 2

MUCINEX SINUS-MAX   NIGHT TIME CONGESTION AND COUGH
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 63824-262
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-262-66	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	03/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/28/2014

Labeler - RB Health (US) LLC (081049410)