4131-gil-phenagil

SPL v8

SPL

SPL Set ID 69fd13a1-2b76-8574-e053-2a91aa0a27e7

Route

ORAL

Published

Effective Date 2018-04-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (10 mg) Chlorpheniramine (3.5 mg)

Inactive Ingredients

Magnesium Stearate Silicon Dioxide Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 322;GIL Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-12-14

Description

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

Medication Information

Description

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

Uses

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

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50565-1

Keep out of the reach of children.

Section 51727-6

Magnesium Stearate, Microcrystalline Cellulose and Silica.

Section 51945-4

NDC 58552-322-01

PHENAGIL

ANTIHISTAMINE AND NASAL DECONGESTANT

SUGAR FREE AND DYE FREE

Each tablet contains:

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCI 10 mg

100 Tablets

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

Section 53413-1

Questions? Call 787-848-9114

Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716

Section 53414-9

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

Section 55105-1

Purposes

Antihistamine

Nasal Decongestant

Directions

Adults and Children12 years of age and over:	take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours
Children 6 to under 12 years of age:	1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period
Children under 6 years of age:	Consult a physician.

Do Not Use

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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Other Informaton

• store at room temperature, USP

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

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

Stop Use and Ask A Doctor If

• nervousness, dizziness, or sleeplessness occurs

• symptoms do not improve within 7 days or occur with a fever.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 51727-6 (51727-6)

Magnesium Stearate, Microcrystalline Cellulose and Silica.

Section 51945-4 (51945-4)

NDC 58552-322-01

PHENAGIL

ANTIHISTAMINE AND NASAL DECONGESTANT

SUGAR FREE AND DYE FREE

Each tablet contains:

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCI 10 mg

100 Tablets

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

Section 53413-1 (53413-1)

Questions? Call 787-848-9114

Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716

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

Directions

Adults and Children12 years of age and over:	take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours
Children 6 to under 12 years of age:	1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period
Children under 6 years of age:	Consult a physician.

Do Not Use (Do not use)

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Other Informaton

• store at room temperature, USP

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

When Using This Product (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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• nervousness, dizziness, or sleeplessness occurs

• symptoms do not improve within 7 days or occur with a fever.

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "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", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "50565-1": "Keep out of the reach of children.", "51727-6": "Magnesium Stearate, Microcrystalline Cellulose and Silica.", "51945-4": "NDC 58552-322-01 PHENAGIL ANTIHISTAMINE AND NASAL DECONGESTANT SUGAR FREE AND DYE FREE Each tablet contains: Chlorpheniramine Maleate 3.5 mg Phenylephrine HCI 10 mg 100 Tablets MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716", "53413-1": "Questions? Call 787-848-9114 Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purposes Antihistamine Nasal Decongestant", "Directions": "Adults and Children12 years of age and over: take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours Children 6 to under 12 years of age: 1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period Children under 6 years of age: Consult a physician.", "Do not use": "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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "Drug Facts": "Active Ingredients (in each tablet) Chlorpheniramine Maleate 3.5 mg Phenylephrine HCl 10 mg", "Other Informaton": "• store at room temperature, USP • do not use if imprinted safety seal under cap is broken or missing.", "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", "Stop use and ask a doctor if": "• nervousness, dizziness, or sleeplessness occurs • symptoms do not improve within 7 days or occur with a fever.", "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", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:01.992833 · Updated: 2026-03-14T23:12:59.392851