4060-giltuss Cough & Cold Tablets

4060-giltuss Cough & Cold Tablets
SPL v7
SPL
SPL Set ID 8590fcc9-c0dd-f43b-e053-2991aa0a692e
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) Dextromethorphan (28 mg) Phenylephrine (10 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Dihydrate Hypromellose, Unspecified Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Light Mineral Oil Povidone K30 Silicon Dioxide Sodium Lauryl Sulfate Stearic Acid Titanium Dioxide Triacetin Talc Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: GILGIL;303303 Shape: oval Color: white Size: 19 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-01
Description

Active Ingredients (in each tablet) Dextromethorphan HBr, 28 mg 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, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

Dosage and Administration

Directions

• Adults and Children 12 years and over:Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period.

• Children 6 to 12 years of age:Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period.

• Children under 6 years of age: Consult a physician.

Description

Active Ingredients (in each tablet) Dextromethorphan HBr, 28 mg Guaifenesin, 388 mg Phenylephrine HCl, 10 mg

Section 42229-5

Other information

  • Store at room temperature, USP
  • Do not use if blister seal is broken
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 usemore 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.
Section 51727-6

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

Section 51945-4

MAXIMUM STRENGTH

Giltuss ®

COUGH & COLD

20 TABLETS

SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

RELIEVES

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

Section 53413-1

Questions or Comments? Call 787-848-9114, Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9

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

Section 55105-1

Purposes

Antitussive

Expectorant

Nasal Decongestant

Drug Facts

Active Ingredients (in each tablet)

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Structured Label Content

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, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

Dosage and Administration (34068-7)

Directions

• Adults and Children 12 years and over:Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period.

• Children 6 to 12 years of age:Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period.

• Children under 6 years of age: Consult a physician.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Other information

  • Store at room temperature, USP
  • Do not use if blister seal is broken
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 usemore 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.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

Giltuss ®

COUGH & COLD

20 TABLETS

SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

RELIEVES

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

Section 53413-1 (53413-1)

Questions or Comments? Call 787-848-9114, Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Antitussive

Expectorant

Nasal Decongestant

Drug Facts

Active Ingredients (in each tablet)

Dextromethorphan HBr, 28 mg

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: 2026-02-15T12:05:42.561631 · Updated: 2026-03-14T23:12:59.392851