Pecgen®

Pecgen®
SPL v5
SPL
SPL Set ID a627824c-5e3d-4672-a047-6c801b50b432
Route
ORAL
Published
Effective Date 2019-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (187 mg)
Inactive Ingredients
Citric Acid Monohydrate Menthol, Unspecified Form Methylparaben Polyethylene Glycol 1000 Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-04-01

Description

Dextromethorphan HBr, 10 mg Guaifenesin, 187 mg

Purpose

Antitussive Expectorant


Medication Information

Purpose

Antitussive Expectorant

Description

Dextromethorphan HBr, 10 mg Guaifenesin, 187 mg

Uses

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

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive.

Section 42229-5

Contains the same active ingredients as Trispec® DMX*

Sugar, Alcohol, Dye and Gluten FREE

CHERRY RASPBERRY FLAVOR

Manufactured in the USA for Kramer Novis

*Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Antitussive

Expectorant

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.

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)

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

When using this product, do not use more than directed.

Stop use and ask a doctor if

• 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.

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

Packaging

Directions

Take every 4 hours, or as directed by a doctor.

Drug Facts

Other Information

• Store at controlled room temperature 15°-30°C (59°-86°F).

• Avoid excessive heat or humidity.

Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.

Inactive Ingredients

Citric acid, flavors, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments?

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072. San Juan, PR 00917

www.kramernovis.com

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr, 10 mg

Guaifenesin, 187 mg


Structured Label Content

Uses

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

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive.

Section 42229-5 (42229-5)

Contains the same active ingredients as Trispec® DMX*

Sugar, Alcohol, Dye and Gluten FREE

CHERRY RASPBERRY FLAVOR

Manufactured in the USA for Kramer Novis

*Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Antitussive

Expectorant

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.

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)

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

When using this product, do not use more than directed.

Stop use and ask a doctor if

• 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.

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

Packaging

Directions

Take every 4 hours, or as directed by a doctor.

Drug Facts

Other Information (Other information)

• Store at controlled room temperature 15°-30°C (59°-86°F).

• Avoid excessive heat or humidity.

Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.

Inactive Ingredients (Inactive ingredients)

Citric acid, flavors, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments? (Questions or comments?)

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072. San Juan, PR 00917

www.kramernovis.com

Active Ingredients (in Each 5 Ml Tsp) (Active Ingredients (in each 5 mL tsp))

Dextromethorphan HBr, 10 mg

Guaifenesin, 187 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)