Gilphex ®

Gilphex ®
SPL v1
SPL
SPL Set ID 87d867fd-e78d-4fbd-a5e4-5fcbb70559a3
Route
ORAL
Published
Effective Date 2022-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (390 mg) Phenylephrine (10 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 304;Gil Shape: capsule Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-05-05

Description

Active Ingredients (in each tablet) Guaifenesin 390 mg Phenylephrine HCl 10 mg

Purpose

Expectorant Nasal Decongestant


Medication Information

Purpose

Expectorant Nasal Decongestant

Description

Active Ingredients (in each tablet) Guaifenesin 390 mg Phenylephrine HCl 10 mg

Uses

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

Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive,clear stuffy nose,clear nasal passageways, shrinks swollen membranes.

Section 50565-1

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case or accidental overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide, Stearic Acid.

Section 53414-9

Section 60561-8
  • store at room temperature, USP.
  • do not use if imprinted safety seal under cap is broken or missing.
Purposes

Expectorant

Nasal Decongestant

Warnings

Do not use this product more than the recommended dosage, or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Directions

Do not exceed recommended doses in a  24 hour period

  • Adults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
  • Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours.
  • Children under 6 years of age: ask a doctor.
Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 390 mg

Phenylephrine HCl 10 mg

Questions? Call 787 848 9114

Manufactured for:

GIL PHARMACEUTICAL CORP.,

Ponce, Puerto Rico 00716

Manufactured by :

Syntho Pharmaceuticals, Inc.

Farmingdale, New York (NY) 11735

Revised Label: 03-22

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occurs.
  • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus).
  • cough and congestion do not improve within 7 days or tend to recur.

These could be signs of  a serious condition.

Ask A Doctor Before Use If You Have
  • heart disease.
  • excessive phlegm (mucus).
  •  high blood pressure.
  • diabetes.
  • thyroid disease.
  • difficulty in urination due to enlargement of the prostate gland.
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Package Label.principal Display Panel

Gilphex ® Total Release - NDC-66576-336-01 - 100's Bottle Label


Structured Label Content

Uses

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

Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive,clear stuffy nose,clear nasal passageways, shrinks swollen membranes.

Section 50565-1 (50565-1)

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case or accidental overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide, Stearic Acid.

Section 53414-9 (53414-9)

Section 60561-8 (60561-8)
  • store at room temperature, USP.
  • do not use if imprinted safety seal under cap is broken or missing.
Purposes

Expectorant

Nasal Decongestant

Warnings

Do not use this product more than the recommended dosage, or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Directions

Do not exceed recommended doses in a  24 hour period

  • Adults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
  • Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours.
  • Children under 6 years of age: ask a doctor.
Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 390 mg

Phenylephrine HCl 10 mg

Questions? Call 787 848 9114 (Questions? Call 787-848-9114)

Manufactured for:

GIL PHARMACEUTICAL CORP.,

Ponce, Puerto Rico 00716

Manufactured by :

Syntho Pharmaceuticals, Inc.

Farmingdale, New York (NY) 11735

Revised Label: 03-22

Stop Use and Ask A Doctor If (Stop use and ask a doctor If)
  • nervousness, dizziness, or sleeplessness occurs.
  • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus).
  • cough and congestion do not improve within 7 days or tend to recur.

These could be signs of  a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease.
  • excessive phlegm (mucus).
  •  high blood pressure.
  • diabetes.
  • thyroid disease.
  • difficulty in urination due to enlargement of the prostate gland.
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Gilphex ® Total Release - NDC-66576-336-01 - 100's Bottle Label


Advanced Ingredient Data


Raw Label Data

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