PHARBINEX-PE- guaifenesin 400mg and phenylephrine hcl 10mg tablet, coated

Pharbinex-PE by

Drug Labeling and Warnings

Pharbinex-PE by is a Otc medication manufactured, distributed, or labeled by Ulai Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Guaifenesin 400mg

Phenylephrine HCl 10mg

Purpose

Expectorant

Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps to make cough more productive
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• promotes nasal and/or sinus drainage
• temporarily relieves sinus congestion and pressure

WARNINGS

Do not use

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to an enlarged prostate gland
• cough accompanied by too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days, or are accompanied by a fever
• cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, 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 caplet every 4 hours as needed

• children 6 to under 12 years of age:

  take ½ caplet every 4 hours as needed

• children under 6 years of age:

  ask a doctor

Other information

store at 200- 250C (680-770F)

Inactive ingredients

croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

Questions or comments?

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

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

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

PRINCIPAL DISPLAY PANEL

PHARBEST 

NDC: 73057-389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg

Phenylephrine HCl 10mg

Expectorant & 

Nasal Decongestant

30 CAPLETS

INGREDIENTS AND APPEARANCE

PHARBINEX-PE 
guaifenesin 400mg and phenylephrine hcl 10mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73057-389
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	PH043
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73057-389-04	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/18/2019

Labeler - Ulai Health LLC (081181535)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(73057-389) , analysis(73057-389) , pack(73057-389) , label(73057-389)