Zyncof

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (400 mg)

Inactive Ingredients

Citric Acid Monohydrate Eucalyptus Oil Glycerin Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-06-01

Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, 20 mg Guaifenesin, 400 mg

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 42229-5

Kramer Novis Pharmaceuticals within reach of patients

NO SUGAR
NO ALCOHOL • NO DYE
NO SACCHARIN • NO ASPARTAME

Specially formulated for patients with High Blood Pressure

Decongestant Free

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

Grape Flavor

Manufactured in USA with imported ingredients for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Section 43683-2

Directions: (The following changes were made)

mL=milliliter
A table was included with the dosage instructions according to age:

age	dose
Adults and children 12 years of age and over	1 teaspoon (5mL) every 4 hours
Children under 12 years of age	do not use

Section 50565-1

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

Purposes

Cough suppressant

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 phelgm (mucus) • 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 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 6 doses in any 24-hour period. • mL=milliliter

age	dose
Adults and children 12 years of age and over	1 teaspoon (5 mL) every 4 hours
Children under 12 years of age	do not use

Drug Facts

Other Information

• Tamper evident feature: Do not use if printed security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity.

Inactive Ingredients

citric acid, eucalyptus oil, flavors, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions Or Comments?

1-787-767-2072

You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST

Active Ingredients (in Each 5 Ml, 1 Teaspoon)

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Structured Label Content

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 42229-5 (42229-5)

Kramer Novis Pharmaceuticals within reach of patients

NO SUGAR
NO ALCOHOL • NO DYE
NO SACCHARIN • NO ASPARTAME

Specially formulated for patients with High Blood Pressure

Decongestant Free

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

Grape Flavor

Manufactured in USA with imported ingredients for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Section 43683-2 (43683-2)

Directions: (The following changes were made)

mL=milliliter
A table was included with the dosage instructions according to age:

age	dose
Adults and children 12 years of age and over	1 teaspoon (5mL) every 4 hours
Children under 12 years of age	do not use

Section 50565-1 (50565-1)

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

Purposes

Cough suppressant

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 phelgm (mucus) • 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 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 6 doses in any 24-hour period. • mL=milliliter

age	dose
Adults and children 12 years of age and over	1 teaspoon (5 mL) every 4 hours
Children under 12 years of age	do not use

Drug Facts

Other Information (Other information)

• Tamper evident feature: Do not use if printed security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity.

Inactive Ingredients (Inactive ingredients)

citric acid, eucalyptus oil, flavors, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions Or Comments? (Questions or comments? )

1-787-767-2072

You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST

Active Ingredients (in Each 5 Ml, 1 Teaspoon) (Active ingredients (in each 5 mL, 1 teaspoon))

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes", "42229-5": "Kramer Novis Pharmaceuticals within reach of patients NO SUGAR NO ALCOHOL • NO DYE NO SACCHARIN • NO ASPARTAME Specially formulated for patients with High Blood Pressure Decongestant Free COUGH SUPPRESSANT Dextromethorphan HBr EXPECTORANT Guaifenesin Grape Flavor Manufactured in USA with imported ingredients for Kramer Novis San Juan, PR 00917 www.kramernovis.com ", "43683-2": "Directions: (The following changes were made) mL=milliliter A table was included with the dosage instructions according to age: age dose Adults and children 12 years of age and over 1 teaspoon (5mL) every 4 hours Children under 12 years of age do not use", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Purposes": "Cough suppressant 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 phelgm (mucus) • 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 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 6 doses in any 24-hour period. • mL=milliliter age dose Adults and children 12 years of age and over 1 teaspoon (5 mL) every 4 hours Children under 12 years of age do not use ", "Other information": "• Tamper evident feature: Do not use if printed security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity.", "Inactive ingredients": "citric acid, eucalyptus oil, flavors, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose", "Questions or comments? ": "1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST", "Active ingredients (in each 5 mL, 1 teaspoon)": "Dextromethorphan HBr, 20 mg Guaifenesin, 400 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information