Giltuss ®

Giltuss ®
SPL v8
SPL
SPL Set ID 6cfefcd3-110a-4381-91cf-0f71407ac78e
Route
ORAL
Published
Effective Date 2022-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (390 mg) Dextromethorphan (29 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: 303;Gil Shape: oval Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-07

Description

Active Ingredients (in each tablet) Guaifenesin 390 mg. Dextromethorphan HBr 29 mg. Phenylephrine HCl 10 mg.

Purpose

Expectorant Antitussive Nasal Decongestant


Medication Information

Purpose

Expectorant Antitussive Nasal Decongestant

Description

Active Ingredients (in each tablet) Guaifenesin 390 mg. Dextromethorphan HBr 29 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, and shrinks swollen membranes.

Section 50565-1

Section 53414-9

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

Purposes

Expectorant

Antitussive

Nasal Decongestant

Warnings

Do not usethis 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.

Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 390 mg.

Dextromethorphan HBr 29 mg.

Phenylephrine HCl 10 mg.

Directions 

Do not exceed recommended doses in a 24 hour period

  • Adults and Children 12 years and over:1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours.
  • Children 6 to 12 years:1/2 tablet every 6 to 8 hours. Do not exceed 2 tablets in 24 hours.
  • Children under 6 years of age: ask a doctor.

Other Information

• store at room temperature, USP.

• do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

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

Questions? Call 787 848 9114

Manufactured for:

GIL PHARMACEUTICAL CORP.

Ponce, Puerto Rico 00716

Label revised: 04/22

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

Giltuss ®Total Release - NDC-58552-335-01 - 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, and shrinks swollen membranes.

Section 50565-1 (50565-1)

Section 53414-9 (53414-9)

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

Purposes

Expectorant

Antitussive

Nasal Decongestant

Warnings

Do not usethis 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.

Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 390 mg.

Dextromethorphan HBr 29 mg.

Phenylephrine HCl 10 mg.

Directions 

Do not exceed recommended doses in a 24 hour period

  • Adults and Children 12 years and over:1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours.
  • Children 6 to 12 years:1/2 tablet every 6 to 8 hours. Do not exceed 2 tablets in 24 hours.
  • Children under 6 years of age: ask a doctor.

Other Information (Other information)

• store at room temperature, USP.

• do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

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

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

Manufactured for:

GIL PHARMACEUTICAL CORP.

Ponce, Puerto Rico 00716

Label revised: 04/22

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)

Giltuss ®Total Release - NDC-58552-335-01 - 100's Bottle Label.


Advanced Ingredient Data


Raw Label Data

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