SPL v8
SPL
SPL Set ID 8591003c-c2ec-df65-e053-2a91aa0a42fb
Route
ORAL
Published
Effective Date 2019-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: GIL;322 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-17 Until 2023-01-01
Description

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

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • nasal congestion
  • itching of the nose or throat
  • sinus congestion and pressure

Dosage and Administration

Directions

adults and children 12 years and over

  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours
  • children 6 to under 12 years of age:take 1/2 tablet every 4 hours, not to exceed 3 tablets in a 24 hour period
  • do not use this product for children under 6 years of age
Description

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

Section 42229-5

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

Section 44425-7

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 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

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 aretaking 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

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

Magnesium Stearate, Microcrystalline Cellulose and Silica.

Section 51945-4

MAXIMUM STRENGTH

NO PSEUDOEPHEDRINE

Giltuss®-D

ALLERGY & CONGESTION

20 TABLETS

SUGAR FREE. ALCOHOL FREE. DYE FREE. SODIUM FREE

RELIEVES

  • SNEEZING
  • RUNNY NOSE
  • ITCHY, WATERY EYES
  • ITCHY THROAT OR NOSE
  • SINUS PRESSURE
  • STUFFY NOSE

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

Antihistamine

Nasal Decongestant

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • nasal congestion
  • itching of the nose or throat
  • sinus congestion and pressure

Dosage and Administration (34068-7)

Directions

adults and children 12 years and over

  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours
  • children 6 to under 12 years of age:take 1/2 tablet every 4 hours, not to exceed 3 tablets in a 24 hour period
  • do not use this product for children under 6 years of age
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

Section 44425-7 (44425-7)

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 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

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 aretaking 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

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

Magnesium Stearate, Microcrystalline Cellulose and Silica.

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

NO PSEUDOEPHEDRINE

Giltuss®-D

ALLERGY & CONGESTION

20 TABLETS

SUGAR FREE. ALCOHOL FREE. DYE FREE. SODIUM FREE

RELIEVES

  • SNEEZING
  • RUNNY NOSE
  • ITCHY, WATERY EYES
  • ITCHY THROAT OR NOSE
  • SINUS PRESSURE
  • STUFFY NOSE

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

Antihistamine

Nasal Decongestant

Drug Facts

Active Ingredients (in each tablet)

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: 2026-02-15T12:05:42.564395 · Updated: 2026-03-14T23:12:59.392851