MUCINEX- guaifenesin tablet, extended release 
Bryant Ranch Prepack

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Mucinex®

Drug Facts

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

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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

Other information

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

HOW SUPPLIED

NDC: 63629-7115-1: 30 Tablets in a BOTTLE

NDC: 63629-7115-2: 20 Tablets in a BOTTLE

NDC: 63629-7115-3: 60 Tablets in a BOTTLE

NDC: 63629-7115-4: 40 Tablets in a BOTTLE

NDC: 63629-7115-5: 14 Tablets in a BOTTLE

Mucinex ER 600mg Tablet

Label
MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-7115(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 Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-7115-130 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
2NDC:63629-7115-220 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2016
3NDC:63629-7115-360 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
4NDC:63629-7115-440 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2019
5NDC:63629-7115-514 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128207/03/2012
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-7115) , RELABEL(63629-7115)

Revised: 9/2022
Document Id: 754211c8-8a60-4d70-b7ca-61f6def1e53f
Set id: a898b584-e17e-45c4-8a28-9f686b95dca0
Version: 10
Effective Time: 20220901
 
Bryant Ranch Prepack