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

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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Drug Facts

Active ingredients (in each caplet)

Guaifenesin 400mg

Phenylephrine HCl 10mg

Purpose

Expectorant

Nasal decongestant

Uses

Do not use

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 20 0- 25 0C (68 0-77 0F)

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

PHARBEST 

NDC 73057-389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg

Phenylephrine HCl 10mg

Expectorant & 

Nasal Decongestant

30 CAPLETS

Pharbinex PE Caplet Product Label Image

PHARBINEX-PE 
guaifenesin 400mg and phenylephrine hcl 10mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-389
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore2 pieces
ShapeCAPSULESize19mm
FlavorImprint Code PH043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73057-389-0430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/18/2019
Labeler - Ulai Health LLC (081181535)

Revised: 1/2022
Document Id: d6e72936-4449-f5a0-e053-2995a90a07fa
Set id: e459bb83-b1d6-42fc-aa46-99ad117e6144
Version: 2
Effective Time: 20220131
 
Ulai Health LLC