G-tusicof®

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Menthol, Unspecified Form Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-09-24

Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr, 20 mg Guaifenesin, 400 mg Phenylephrine HCl, 10 mg

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation

Section 42229-5

G-TUSICOF^®

Compare to tusicof^®

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR & ALCOHOL FREE

NO SACCHARIN - NO SROBITOL

NO ASPARTAME - NO DYE

NO PHENYLPROPANOLAMINE

Kramer Novis

Pharmaceuticals within reach of patients

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Cough suppressant

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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (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 • 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 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

Active Ingredients

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Phenylephrine HCl, 10 mg

Inactive Ingredients

artificial flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Question Or Comments?

1-787-767-2072

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

Structured Label Content

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation

Section 42229-5 (42229-5)

G-TUSICOF^®

Compare to tusicof^®

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR & ALCOHOL FREE

NO SACCHARIN - NO SROBITOL

NO ASPARTAME - NO DYE

NO PHENYLPROPANOLAMINE

Kramer Novis

Pharmaceuticals within reach of patients

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Cough suppressant

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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (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 • 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 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

Active Ingredients (Active ingredients)

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Phenylephrine HCl, 10 mg

Inactive Ingredients (Inactive ingredients)

artificial flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Question Or Comments? (Question or comments?)

1-787-767-2072

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

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 a cold: • nasal congestion • cough due to minor throat and bronchial irritation", "42229-5": "G-TUSICOF ® Compare to tusicof ® Dextromethorphan HBr COUGH SUPPRESSANT Guaifenesin EXPECTORANT Phenylephrine HCl NASAL DECONGESTANT SUGAR & ALCOHOL FREE NO SACCHARIN - NO SROBITOL NO ASPARTAME - NO DYE NO PHENYLPROPANOLAMINE Kramer Novis Pharmaceuticals within reach of patients 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 accidental overdose, get medical help or contact a Poison Control Center right away.", "Purposes": "Cough suppressant 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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (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 • 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 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", "Active ingredients": "Dextromethorphan HBr, 20 mg Guaifenesin, 400 mg Phenylephrine HCl, 10 mg", "Inactive ingredients": "artificial flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose", "Question or comments?": "1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information