MUCUS RELIEF EXTENDED RELEASE- guaifenesin tablet 
Cardinal Health 107, LLC

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Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes 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 (1-800-222-1222).

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 tablet every 12 hours. Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use 

Other information

store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Packaged and Distributed By:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268 USA

Refer to package label for Distributor's NDC Number

Distributed By:

Cardinal Health

Dublin, OH 43017

L5769245-10124

L5769245-20124

Package Label

Mucus Relief ER

Guaifenesin 600 mg

Expectorant

10 Extended-Release Tablets

Bag Label
MUCUS RELIEF EXTENDED RELEASE 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4153(NDC:0904-6718)
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code AN036
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-4153-010 in 1 BAG09/30/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20734209/30/2018
Labeler - Cardinal Health 107, LLC (118546603)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675REPACK(55154-4153)

Revised: 1/2024
Document Id: 5e9c9c31-a38b-4eca-84f6-8602fa40bd36
Set id: f7abc2ff-21bc-48b5-9989-c5ac84f5c9cd
Version: 2
Effective Time: 20240112
 
Cardinal Health 107, LLC