Relieve Allergy And Congestion With:

Relieve Allergy And Congestion With:
SPL v1
SPL
SPL Set ID 80200dc8-858e-43a4-965a-0ff7487046ad
Route
ORAL
Published
Effective Date 2022-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (3.5 mg) Phenylephrine (10 mg)
Inactive Ingredients
Lactose Monohydrate Hypromellose, Unspecified Microcrystalline Cellulose Magnesium Stearate Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 322;Gil Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-06-15

Description

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

Purpose

Antihistamine Nasal Decongestant


Medication Information

Purpose

Antihistamine Nasal Decongestant

Description

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

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 50565-1

Section 53414-9

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

Purposes

Antihistamine

Nasal Decongestant

Warnings

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.

Directions
  • Adults and children 12 years and over.

    Take 1 tablet every 4 hours.

    Do not take more than 6 tablets in a 24 hours.
  • Children 6 to 12 years of age: : Take 1/2 tablet every 4 hours, Do not to exceed 3 tablets in a 24 hour period.
  • Do not use this product children under 6 years of age.
Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Other Information

• store at room temperature, USP.

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

Inactive Ingredients

Hydroxypropyl Methylcellulose, Lactose Monohydrate, Magnesium Stearate,

Microcrystalline Cellulose and Polyethylene Glycol.

Questions? Call 787 848 9114

Manufactured for:

GIL PHARMACEUTICAL CORP.,

Ponce, Puerto Rico 00716



Manufactured by:

Syntho Pharmaceuticals, Inc.

Farmingdale, New York (NY) 11735

Label revised: 04/22

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.

Package Label.principal Display Panel

PHENAGIL- NDC- 66576-322-01- 100's Bottle Label.

Ask A Doctor Or Pharmacist Before You Use If You Are Taking Sedatives Or Tranquilizers.

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.

Structured Label Content

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 50565-1 (50565-1)

Section 53414-9 (53414-9)

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

Purposes

Antihistamine

Nasal Decongestant

Warnings

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.

Directions
  • Adults and children 12 years and over.

    Take 1 tablet every 4 hours.

    Do not take more than 6 tablets in a 24 hours.
  • Children 6 to 12 years of age: : Take 1/2 tablet every 4 hours, Do not to exceed 3 tablets in a 24 hour period.
  • Do not use this product children under 6 years of age.
Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Other Information (Other information)

• store at room temperature, USP.

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

Inactive Ingredients

Hydroxypropyl Methylcellulose, Lactose Monohydrate, Magnesium Stearate,

Microcrystalline Cellulose and Polyethylene Glycol.

Questions? Call 787 848 9114 (Questions? Call 787-848-9114)

Manufactured for:

GIL PHARMACEUTICAL CORP.,

Ponce, Puerto Rico 00716



Manufactured by:

Syntho Pharmaceuticals, Inc.

Farmingdale, New York (NY) 11735

Label revised: 04/22

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

PHENAGIL- NDC- 66576-322-01- 100's Bottle Label.

Ask A Doctor Or Pharmacist Before You Use If You Are Taking Sedatives Or Tranquilizers. (Ask a doctor or pharmacist before you use if you are taking sedatives or tranquilizers.)

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.

Advanced Ingredient Data


Raw Label Data

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