PHARBINEX-PE- guaifenesin 400mg and phenylephrine hcl 10mg tablet, coated 
Pharbest Pharmaceuticals, Inc.

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

Temporarily relieves symptoms associated with cough, the common cold, hay fever or upper respiratory allergies

Warnings

Do not exceed recommended dosage.

Do not use

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm (mucus)
  • difficulty in urination due to enlargement of prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash or persistent headache
  • cough and congestion do not improve within 7 days or tend to recur

These could be signs 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 meals
  • do not exceed 6 doses in 24 hours or as directed by 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

consult a doctor

Other information

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?

Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM

PHARBEST 

NDC 16103-0389-04

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:16103-389
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) PHENYLEPHRINE10 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, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size19mm
FlavorImprint Code PH043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-389-041 in 1 CARTON05/01/2018
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2018
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-389) , analysis(16103-389) , pack(16103-389) , label(16103-389)

Revised: 5/2018
Document Id: 0615f444-f14a-426f-975a-822f67e0a79f
Set id: cad73d08-a439-446f-aaa9-d1fd18ec1e54
Version: 1
Effective Time: 20180501
 
Pharbest Pharmaceuticals, Inc.