MUCINEX- guaifenesin tablet, extended release

Mucinex by

Drug Labeling and Warnings

Mucinex 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 (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

• for children under 12 years of age

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regard for the timing of meals
• adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

NDC: 63824-008-32

Mucinex®

600 mg guaifenesin
extended-release bi-layer tablets

EXPECTORANT

12
HOUR®

✓ Relieves Chest Congestion
✓ Thins and Loosens Mucus
✓ Immediate and Extended Release

20
EXTENDED-RELEASE
BI-LAYER TABLETS

INGREDIENTS AND APPEARANCE

MUCINEX 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	600 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (blue and white)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Mucinex;600
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-008-36	1 in 1 CARTON	07/03/2012
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63824-008-32	1 in 1 CARTON	07/03/2012
2		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63824-008-34	2 in 1 CARTON	07/03/2012
3		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 63824-008-69	3 in 1 CARTON	07/03/2012
4		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 63824-008-27	4 in 1 CARTON	07/03/2012
5		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 63824-008-15	5 in 1 CARTON	07/03/2012
6		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 63824-008-74	24 in 1 CARTON	07/03/2012
7	NDC: 63824-008-73	2 in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 63824-008-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2012
9	NDC: 63824-008-72	2 in 1 POUCH; Type 0: Not a Combination Product	07/03/2012
10	NDC: 63824-008-86	4 in 1 CARTON	07/03/2012
10		17 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC: 63824-008-24	2 in 1 CARTON	07/03/2012
11		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
12	NDC: 63824-008-80	4 in 1 CARTON	07/03/2012
12		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
13	NDC: 63824-008-92	6 in 1 CARTON	07/03/2012
13		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
14	NDC: 63824-008-17	25 in 1 CARTON	10/01/2018
14	NDC: 63824-008-72	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
NDA	NDA021282	07/03/2012

Labeler - RB Health (US) LLC (081049410)