MUCUS RELIEF- guaifenesin tablet
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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major 272R

ACTIVE INGREDIENT: Each immediate-release tablet contains – Guaifenesin 400 mg

PURPOSE: Expectorant

KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or contact a Poison Control Center right away

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus.

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 excessive phlegm (mucus)

Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Generic Section

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Refer to package label for Distributor's NDC Number

Principal Display Panel

Mucus Relief

Guaifenesin 400 mg

30 Tablets

label

MUCUS RELIEF
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6232(NDC:49483-272)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	TCL272
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6232-46	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2012	03/31/2021
2	NDC:0904-6232-52	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2012	03/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/23/2012	03/31/2021

Labeler - Major Pharmaceuticals (191427277)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Revised: 12/2019

Document Id: 98e12c75-67a4-0483-e053-2a95a90a337a

Set id: ba8c698e-eeec-4067-96c4-b1f81b22a39b

Version: 5

Effective Time: 20191204

Major Pharmaceuticals