MUCUS RELIEF EXTENDED RELEASE- guaifenesin tablet

Mucus Relief Extended Release by

Drug Labeling and Warnings

Mucus Relief Extended Release by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 107, LLC, Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MUCUS RELIEF EXTENDED RELEASE 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-4153(NDC:0904-6718)
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)
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
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AN036
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-4153-0	10 in 1 BAG	09/30/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207342	09/30/2018

Labeler - Cardinal Health 107, LLC (118546603)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	REPACK(55154-4153)