GUAIFENESIN 200MG- guaifenesin tablet

Guaifenesin 200mg by

Drug Labeling and Warnings

Guaifenesin 200mg by is a Otc medication manufactured, distributed, or labeled by Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Guaifenesin 200 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 too much 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

• 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
• DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

maltodextrin, povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide, stearic acid

Questions or comments?

Call 1-844-832-1138

Monday - Friday 9AM – 5PM

PRINCIPAL DISPLAY PANEL

Guaifenesin 200 mg

Expectorant

INGREDIENTS AND APPEARANCE

GUAIFENESIN 200MG 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71679-148
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	G2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71679-148-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2019
2	NDC: 71679-148-02	200 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/26/2019

Labeler - Health Pharma USA LLC (080804485)

Establishment
Name	Address	ID/FEI	Business Operations
Health Pharma USA LLC		080804485	manufacture(71679-148)