4062- giltuss sinus & chest congestion tablets

4062- giltuss sinus & chest congestion tablets
SPL v8
SPL
SPL Set ID 8591003c-c2f2-df65-e053-2a91aa0a42fb
Route
oral
Published
Effective Date 2019-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (388 mg) phenylephrine (10 mg)
Inactive Ingredients
stearic acid titanium dioxide triacetin polyethylene glycol 400 croscarmellose sodium hypromellose, unspecified lactose magnesium stearate maltodextrin cellulose, microcrystalline light mineral oil povidone k30 silicon dioxide sodium lauryl sulfate talc

Identifiers & Packaging

Pill Appearance
Imprint: GILGIL;304304 Shape: oval Color: white Size: 19 mm Score: 2
Marketing Status
otc monograph drug active Since 2021-04-01
Description

Active Ingredient (in each tablet) Guaifenesin 388 mg Phenylephrine HCl 10 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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
  • clears stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes
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
Other Information

Other information

  • store at room temperature, USP
  • do not use if blister seal is broken
Description

Active Ingredient (in each tablet) Guaifenesin 388 mg Phenylephrine HCl 10 mg

Section 42229-5

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

Section 50565-1

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Section 50566-9

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.

Section 50569-3

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
Section 50570-1

Do not use

  • more than the recommended dosage
  • this product 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.
Section 51727-6

Inactive ingredients Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

Section 51945-4

MAXIMUM STRENGTH

GILTUSS®

SINUS & CHEST CONGESTION

20 TABLETS

NON-DROWSY. DYE FREE. PRESERVATIVE .SODIUM FREE

RELIEVES

  • STUFFY NOSE
  • NASAL CONGESTION
  • SINUS PRESSURE
  • CHEST CONGESTION
  • LOOSENS PHLEGM AND MUCUS

Section 53413-1

Questions? Call 787-848-9114

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Expectorant

Nasal Decongestant

Drug Facts

Active Ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Indications and Usage (34067-9)

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
  • clears stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes
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
Other Information (Other information)

Other information

  • store at room temperature, USP
  • do not use if blister seal is broken
Section 42229-5 (42229-5)

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • more than the recommended dosage
  • this product 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.
Section 51727-6 (51727-6)

Inactive ingredients Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

GILTUSS®

SINUS & CHEST CONGESTION

20 TABLETS

NON-DROWSY. DYE FREE. PRESERVATIVE .SODIUM FREE

RELIEVES

  • STUFFY NOSE
  • NASAL CONGESTION
  • SINUS PRESSURE
  • CHEST CONGESTION
  • LOOSENS PHLEGM AND MUCUS

Section 53413-1 (53413-1)

Questions? Call 787-848-9114

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Expectorant

Nasal Decongestant

Drug Facts

Active Ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:42.566725 · Updated: 2026-03-14T23:12:59.392851