Neogen®

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (30 mg) Guaifenesin (200 mg) Phenylephrine (7.5 mg)

Inactive Ingredients

Potassium Sorbate Sodium Benzoate Citric Acid Monohydrate Propylene Glycol Sodium Citrate, Unspecified Form Sucrose Sorbitol Glycerin Sucralose Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-10-10

Medication Information

Purpose

Antitussive Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 30 mg Guaifenesin, 200 mg Phenylephrine HCL, 7.5 mg

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

• temporarily relieves these symptoms occurring with the common cold, sinusitis, hay fever or other respiratory allergies.

• nasal congestion

• cough due to minor throat and bronchial irritation

Section 42229-5

Contains the same active ingredients as Neo Tuss^®-D*

DEXTROMETHORPHAN HBr

Antitussive

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCL

Nasal Decongestant

• Alcohol Free • Dye Free

• Codeine Free • Sugar Free

Raspberry Flavor

Manufactured in the USA for Kramer Novis, San Juan, PR 00917.

T:(787) 767-2072 www.kramernovis.com

* Neo Tuss^®-D* is a registered trademark of A.G. Marin Pharmaceuticals. This product is not manufactured, distributed or marketed by A.G. Marin Pharmaceuticals.

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

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.

Ask a doctor before use if you have

• Heart disease • High blood pressure • Thyroid disease • Diabetes • Trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

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.

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

Packaging

Directions

Do not take more than 4 doses in any 24-hour period. Shake well before using.

Every 6-8 hours	Adults and children 12 years of age and over	Take one teaspoonful (5 mL)
Children 6 to under 12 years of age	Take 1/2 teaspoonful (2.5 mL)
Children under 6 years of age	Consult a doctor

Drug Facts

Other Information

• Store at controlled room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat or humidity.

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

Inactive Ingredients

Potassium sorbate, sodium benzoate, citric acid, propylene glycol, sodium citrate, sucrose, sorbitol, vegetable glycerin, sucralose, raspberry flavor and purified water

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr, 30 mg

Guaifenesin, 200 mg

Phenylephrine HCL, 7.5 mg

Structured Label Content

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

• temporarily relieves these symptoms occurring with the common cold, sinusitis, hay fever or other respiratory allergies.

• nasal congestion

• cough due to minor throat and bronchial irritation

Section 42229-5 (42229-5)

Contains the same active ingredients as Neo Tuss^®-D*

DEXTROMETHORPHAN HBr

Antitussive

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCL

Nasal Decongestant

• Alcohol Free • Dye Free

• Codeine Free • Sugar Free

Raspberry Flavor

Manufactured in the USA for Kramer Novis, San Juan, PR 00917.

T:(787) 767-2072 www.kramernovis.com

* Neo Tuss^®-D* is a registered trademark of A.G. Marin Pharmaceuticals. This product is not manufactured, distributed or marketed by A.G. Marin Pharmaceuticals.

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

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.

Ask a doctor before use if you have

• Heart disease • High blood pressure • Thyroid disease • Diabetes • Trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

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.

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

Packaging

Directions

Do not take more than 4 doses in any 24-hour period. Shake well before using.

Every 6-8 hours	Adults and children 12 years of age and over	Take one teaspoonful (5 mL)
Children 6 to under 12 years of age	Take 1/2 teaspoonful (2.5 mL)
Children under 6 years of age	Consult a doctor

Drug Facts

Other Information

• Store at controlled room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat or humidity.

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

Inactive Ingredients

Potassium sorbate, sodium benzoate, citric acid, propylene glycol, sodium citrate, sucrose, sorbitol, vegetable glycerin, sucralose, raspberry flavor and purified water

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

Dextromethorphan HBr, 30 mg

Guaifenesin, 200 mg

Phenylephrine HCL, 7.5 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. • temporarily relieves these symptoms occurring with the common cold, sinusitis, hay fever or other respiratory allergies. • nasal congestion • cough due to minor throat and bronchial irritation", "42229-5": "Contains the same active ingredients as Neo Tuss ® -D* DEXTROMETHORPHAN HBr Antitussive GUAIFENESIN Expectorant PHENYLEPHRINE HCL Nasal Decongestant • Alcohol Free • Dye Free • Codeine Free • Sugar Free Raspberry Flavor Manufactured in the USA for Kramer Novis, San Juan, PR 00917. T:(787) 767-2072 www.kramernovis.com * Neo Tuss ® -D* is a registered trademark of A.G. Marin Pharmaceuticals. This product is not manufactured, distributed or marketed by A.G. Marin Pharmaceuticals.", "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 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. Ask a doctor before use if you have • Heart disease • High blood pressure • Thyroid disease • Diabetes • Trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product do not use more than directed. 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. If pregnant or breast-feeding , ask a health professional before use.", "Directions": "Do not take more than 4 doses in any 24-hour period. Shake well before using. Every 6-8 hours Adults and children 12 years of age and over Take one teaspoonful (5 mL) Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL) Children under 6 years of age Consult a doctor", "Other Information": "• Store at controlled room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat or humidity. • Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.", "Inactive Ingredients": "Potassium sorbate, sodium benzoate, citric acid, propylene glycol, sodium citrate, sucrose, sorbitol, vegetable glycerin, sucralose, raspberry flavor and purified water", "Active Ingredients (in each 5 mL tsp)": "Dextromethorphan HBr, 30 mg Guaifenesin, 200 mg Phenylephrine HCL, 7.5 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information