PHARBINEX- guaifenesin 400mg tablet

Pharbinex by

Drug Labeling and Warnings

Pharbinex by is a Otc medication manufactured, distributed, or labeled by Ulai Health LLC, Pharbest Pharmaceuticals, Inc.. 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 rid the bronchial passageways of bothersome mucus
• helps make cough more productive

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)

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 sings 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

• take with a full glass of water
• this product can be administered without regard for the timing of the meals
• do not exceed 6 doses in 24 hours or as directed by a doctor

• adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
• children 6 to under 12 years of age: take ½ tablet every 4 hours as needed
• children under 6 years of age: ask a doctor

Other information

store at 200- 250C (680-770F)

Inactive ingredients

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

Questions?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of registered trademark Mucinex®

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

PRINCIPAL DISPLAY PANEL

PHARBEST

NDC: 73057-379-04

Manufactured in the USA

Immediate Release

PHARBINEX

*Compare to the active ingredient in Mucinex® Tablets

Guaifenesin 400mg

Expectorant

30 TABLETS

INGREDIENTS AND APPEARANCE

PHARBINEX 
guaifenesin 400mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73057-379
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	capsule	Size	18mm
Flavor		Imprint Code	PH063
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73057-379-04	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/26/2019

Labeler - Ulai Health LLC (081181535)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(73057-379) , analysis(73057-379) , pack(73057-379) , label(73057-379)