Phenagil ®

Phenagil ®
SPL v5
SPL
SPL Set ID a6880389-0dc1-43a7-a73b-77f77bafe51e
Route
ORAL
Published
Effective Date 2022-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (3.5 mg) Dextromethorphan (29 mg) Phenylephrine (10 mg)
Inactive Ingredients
Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 323;Gil Shape: round Color: white Size: 3 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-26

Description

Active ingredients (in each tablet) Chlorpheniramine maleate 3.5 mg Dextromethorphan HBr 29 mg Phenylephrine HCI 10 mg

Purpose

Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Active ingredients (in each tablet) Chlorpheniramine maleate 3.5 mg Dextromethorphan HBr 29 mg Phenylephrine HCI 10 mg

Uses

Temporarily relieves:

• cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.

• nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

• temporarily relieves these symptoms due to hay fever (allergic rhinitis):

  • runny nose.

  • sneezing.

  • itchy, watery eyes.

  • itching of the nose or throat.

  • temporarily restores freer breathing through the nose.

Section 50565-1

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.

Section 53414-9

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

Do not use

• to sedate a child or to make a child sleepy.

• 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 one 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 doctor.

Drug Facts

Active ingredients

(in each tablet)

Chlorpheniramine maleate 3.5 mg

Dextromethorphan HBr 29 mg

Phenylephrine HCI 10 mg

Other Information

• store at room temperature.

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

Inactive Ingredients

Hydroxypropyl Methylcellulose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate and Polyethylene Glycol.

Questions Or Comments?

Call 1-787-848-9114,Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.



MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

Label revised: 04/22

When Using This Product

• do not use more than directed.

• may cause drowsiness.

• avoid alcoholic beverages.

• alcohol, sedatives, and tranquilizers may increase drowsiness.

• be careful when driving a motor vehicle or operating machinery.

• excitability may occur, especially in children.

Stop Use and Ask A Doctor If

• you get nervous, dizzy, or sleepless.

• symptoms do not get better within 7 days or are accompanied by fever.

• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Ask A Doctor Before Use If You Have

• heart disease.

• high blood pressure.

• thyroid disease.

• diabetes.

• trouble urinating due to an enlarged prostate gland.

• glaucoma.

• cough that occurs with too much phlegm (mucus).

• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Package Label.principal Display Panel

PHENAGIL ® CH - NDC 58552-337-01 - 100's Bottle Label.

Ask A Doctor Or Pharmacist Before Use If You Are

• taking sedatives or tranquilizers.

• taking any other oral nasal decongestant or stimulant.


Structured Label Content

Uses

Temporarily relieves:

• cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.

• nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

• temporarily relieves these symptoms due to hay fever (allergic rhinitis):

  • runny nose.

  • sneezing.

  • itchy, watery eyes.

  • itching of the nose or throat.

  • temporarily restores freer breathing through the nose.

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

Do not use

• to sedate a child or to make a child sleepy.

• 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 one 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 doctor.

Drug Facts

Active ingredients

(in each tablet)

Chlorpheniramine maleate 3.5 mg

Dextromethorphan HBr 29 mg

Phenylephrine HCI 10 mg

Other Information (Other information)

• store at room temperature.

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

Inactive Ingredients (Inactive ingredients)

Hydroxypropyl Methylcellulose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate and Polyethylene Glycol.

Questions Or Comments? (Questions or comments?)

Call 1-787-848-9114,Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.



MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

Label revised: 04/22

When Using This Product (When using this product)

• do not use more than directed.

• may cause drowsiness.

• avoid alcoholic beverages.

• alcohol, sedatives, and tranquilizers may increase drowsiness.

• be careful when driving a motor vehicle or operating machinery.

• excitability may occur, especially in children.

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

• you get nervous, dizzy, or sleepless.

• symptoms do not get better within 7 days or are accompanied by fever.

• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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.

• glaucoma.

• cough that occurs with too much phlegm (mucus).

• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

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

PHENAGIL ® CH - NDC 58552-337-01 - 100's Bottle Label.

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

• taking sedatives or tranquilizers.

• taking any other oral nasal decongestant or stimulant.


Advanced Ingredient Data


Raw Label Data

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