SPL v7
SPL
SPL Set ID 85a0dc7f-ffb5-7d52-e053-2991aa0a602a
Route
ORAL
Published
Effective Date 2019-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Chlorpheniramine (3.5 mg) Chlophedianol (24 mg)
Inactive Ingredients
Silicon Dioxide Microcrystalline Cellulose Magnesium Stearate Croscarmellose

Identifiers & Packaging

Pill Appearance
Imprint: GIL;323 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-01
Description

Active Ingredients (in each tablet) Chlophedianol HCl 24 mg Chlorpheniramine Maleate 3.5 mg Phenylephrine HCl 10 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

Temporarily relieves runny nose, sneezing, and itchy and watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

Dosage and Administration

Directions

  • Adults and Children 12 years and over:Take 1 tablet every 6-8 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 6-8 hours. Do not take more than 2 tablets in a 24-hour period.
  • Children under 6 years: Consult a physician.
Description

Active Ingredients (in each tablet) Chlophedianol HCl 24 mg Chlorpheniramine Maleate 3.5 mg Phenylephrine HCl 10 mg

Section 44425-7

Other information

  • store at room temperature, USP
  • do not use if pouch is open or torn
Section 50565-1

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).

Section 50566-9

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

Section 50567-7

When using this product:

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have:

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma
  • chronic bronchitis, or emphysema
  • excessive phlegm (mucus)

Section 50570-1

Do not useif 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.

Section 51727-6

Inactive Ingredients

Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.

Section 51945-4

MAXIMUM STRENGTH

Giltuss® ALLERGY PLUS

COUGH & CONGESTION

20 TABLETS

SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

Relieves

  • Sneezing
  • Runny Nose
  • Itchy & watery eyes
  • Double acting cough supressant
  • Stuffy Nose
  • Sinus Pressure

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

Purposes

Cough Suppressant

Antihistamine

Nasal Decongestant

Drug Facts

Active Ingredients (in each tablet)

Chlophedianol HCl 24 mg

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves runny nose, sneezing, and itchy and watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

Dosage and Administration (34068-7)

Directions

  • Adults and Children 12 years and over:Take 1 tablet every 6-8 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 6-8 hours. Do not take more than 2 tablets in a 24-hour period.
  • Children under 6 years: Consult a physician.
Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • store at room temperature, USP
  • do not use if pouch is open or torn
Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

Section 50567-7 (50567-7)

When using this product:

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have:

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma
  • chronic bronchitis, or emphysema
  • excessive phlegm (mucus)

Section 50570-1 (50570-1)

Do not useif 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.

Section 51727-6 (51727-6)

Inactive Ingredients

Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

Giltuss® ALLERGY PLUS

COUGH & CONGESTION

20 TABLETS

SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

Relieves

  • Sneezing
  • Runny Nose
  • Itchy & watery eyes
  • Double acting cough supressant
  • Stuffy Nose
  • Sinus Pressure

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)

Purposes

Cough Suppressant

Antihistamine

Nasal Decongestant

Drug Facts

Active Ingredients (in each tablet)

Chlophedianol HCl 24 mg

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:42.568412 · Updated: 2026-03-14T23:12:59.392851