Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID e459bb83-b1d6-42fc-aa46-99ad117e6144
Route
ORAL
Published
Effective Date 2019-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Mineral Oil Povidone K30 Povidone K90 Silicon Dioxide Sodium Lauryl Sulfate Stearic Acid Titanium Dioxide Croscarmellose Sodium Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: PH043 Shape: capsule Color: white Size: 19 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-18

Description

Guaifenesin 400mg Phenylephrine HCl 10mg

Purpose

Expectorant Nasal decongestant


Medication Information

Purpose

Expectorant

Nasal decongestant

Description

Guaifenesin 400mg Phenylephrine HCl 10mg

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
Section 42229-5

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

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

Section 50567-7

When using this product do not exceed recommended dosage.

Section 51945-4

PHARBEST 

NDC 73057-389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg

Phenylephrine HCl 10mg

Expectorant & 

Nasal Decongestant

30 CAPLETS

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

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.
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)

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).

Active Ingredients (in Each Caplet)

Guaifenesin 400mg

Phenylephrine HCl 10mg

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

Structured Label Content

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
Section 42229-5 (42229-5)

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

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

Section 51945-4 (51945-4)

PHARBEST 

NDC 73057-389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg

Phenylephrine HCl 10mg

Expectorant & 

Nasal Decongestant

30 CAPLETS

Purpose

Expectorant

Nasal decongestant

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

Do Not Use (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.
Other Information (Other information)

store at 20 0- 25 0C (68 0-77 0F)

Inactive Ingredients (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? (Questions or comments?)

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

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Guaifenesin 400mg

Phenylephrine HCl 10mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

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