MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated

Mucinex Sinus-Max by

Drug Labeling and Warnings

Mucinex Sinus-Max 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)	Purpose
Acetaminophen 325 mg	Pain reliever
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves:
  • nasal congestion
  • headache
  • minor aches and pains
  • sinus congestion and pressure
• 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

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
• blister
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
• 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
• 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

When using this product do not use more than directed

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

croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, 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 - 20 Caplet Blister Pack Carton

MAXIMUM STRENGTH*

NDC: 63824-201-20

Mucinex®
SINUS-MAX®

SEVERE CONGESTION RELIEF

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

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

FOR AGES 12+

20 CAPLETS

INGREDIENTS AND APPEARANCE

MUCINEX SINUS-MAX   SEVERE CONGESTION RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
croscarmellose sodium (UNII: M28OL1HH48)
crospovidone (15 mpa.s at 5%) (UNII: 68401960MK)
FD&C red no. 40 (UNII: WZB9127XOA)
FD&C yellow no. 6 (UNII: H77VEI93A8)
aluminum oxide (UNII: LMI26O6933)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
povidone, unspecified (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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-201-20	2 in 1 CARTON	07/23/2012
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63824-201-30	3 in 1 CARTON	07/23/2012
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63824-201-72	2 in 1 POUCH; Type 0: Not a Combination Product	07/23/2012
4	NDC: 63824-201-44	4 in 1 CARTON	07/23/2012
4	NDC: 63824-201-72	2 in 1 POUCH; 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	07/23/2012

Labeler - RB Health (US) LLC (081049410)