Mucinex: Package Insert - Drugs.com (2024)

Package insert / product label
Generic name: guaifenesin
Dosage form: tablet, extended release
Drug class: Expectorants

Medically reviewed by Drugs.com. Last updated on Sep 10, 2023.

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Indications and Usage for Mucinex

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.

Mucinex Dosage and Administration

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

Storage and Handling

store at 20-25°C (68-77°F)

Inactive ingredients

carbomer hom*opolymer 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.

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

MUCINEX
guaifenesin tablet, extended release

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

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

Ingredient Name	Strength
Inactive Ingredients
*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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	06/15/2022
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	12/31/2020
14	NDC:63824-008-72	2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021282	07/03/2012

Labeler - RB Health (US) LLC(081049410)

Frequently asked questions

Does Mucinex help you get pregnant?
Does Mucinex help with Covid?
Can you take Mucinex and Nyquil together?
Does Mucinex help with a sore throat?
I have high blood pressure. Can I take Mucinex DM safely?
What is the difference between Mucinex D and Mucinex DM?
Can I take Claritin with Mucinex DM?
Has anyone used expired Mucinex and had it worked?
Is it OK to take Excedrin with Mucinex D?

View more FAQ

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Drug class: expectorants
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Professional resources

Guaifenesin monograph
Guaifenesin Tablets (FDA)

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Mucinex DM

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