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Mucinex: Package Insert / Prescribing Info

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.

Drug Facts

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 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.

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

Principal Display Panel - 20 Tablet Blister Pack Carton
MUCINEX
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (blue and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;600
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-008-361 in 1 CARTON07/03/2012
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-008-321 in 1 CARTON07/03/2012
220 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-008-342 in 1 CARTON07/03/2012
320 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63824-008-693 in 1 CARTON07/03/2012
420 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:63824-008-274 in 1 CARTON07/03/2012
518 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:63824-008-155 in 1 CARTON07/03/2012
620 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:63824-008-7424 in 1 CARTON07/03/2012
7NDC:63824-008-732 in 1 POUCH; Type 0: Not a Combination Product
8NDC:63824-008-50500 in 1 BOTTLE; Type 0: Not a Combination Product07/03/2012
9NDC:63824-008-722 in 1 POUCH; Type 0: Not a Combination Product07/03/2012
10NDC:63824-008-864 in 1 CARTON07/03/2012
1017 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:63824-008-242 in 1 CARTON07/03/201206/15/2022
1112 in 1 BLISTER PACK; Type 0: Not a Combination Product
12NDC:63824-008-804 in 1 CARTON07/03/2012
1220 in 1 BLISTER PACK; Type 0: Not a Combination Product
13NDC:63824-008-926 in 1 CARTON07/03/2012
1320 in 1 BLISTER PACK; Type 0: Not a Combination Product
14NDC:63824-008-1725 in 1 CARTON10/01/201812/31/2020
14NDC:63824-008-722 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128207/03/2012
Labeler - RB Health (US) LLC (081049410)

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