MUCUS RELIEF- guaifenesin 400 mg tablet

Mucus Relief by

Drug Labeling and Warnings

Mucus Relief by is a Otc medication manufactured, distributed, or labeled by HealthLife of USA LLC, Elysium Pharmaceutical Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

Warnings

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)

When using this product

• do not exceed recommended dosage
• do not use for more than 7 days

Stop use and ask a doctor if

• cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

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:

• adults and children 12 years of age and over: 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: do not use

Other information

• each tablet contains: sodium 1.24 mg VERY LOW SODIUM
• store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
• keep in a dry place and do not expose to heat
• read all product information before using
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions or Comments

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN Guai-Aid® 400*

Guaifenesin 400 mg

Expectorant

* This product is not manufactured or distributed by Health Products Express, Inc., owner of the registered trademark Guai-Aid® 400.

INGREDIENTS AND APPEARANCE

MUCUS RELIEF 
guaifenesin 400 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-119
Route of Administration	ORAL

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

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

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	EB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-119-25	25 in 1 CARTON	04/13/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69517-119-50	50 in 1 CARTON	04/13/2016
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 69517-119-02	2 in 1 POUCH	04/13/2016
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 69517-119-10	1000 in 1 BOTTLE	04/13/2016
4	NDC: 69517-119-05	500 in 1 BOTTLE
4	NDC: 69517-119-12	12 in 1 BOTTLE
4		1 in 1 CARTON; Type 0: Not a Combination Product
5	NDC: 69517-119-16	1 in 1 CARTON	06/05/2017
5		16 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/13/2016

Labeler - HealthLife of USA LLC (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceutical Ltd.		915664486	manufacture(69517-119)