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 2010-08-17

Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr, 20mg 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

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR & ALCOHOL FREE

NO SACCHARIN - NO SORBITOL

NO ASPARTAME - NO DYE

NO PHENYLPROPANOLAMINE

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.

Inactive Ingredients

artificial flavor, citric acid, 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, 20mg

Guaifenesin, 400 mg

Phenylephrine HCl, 10 mg

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)

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR & ALCOHOL FREE

NO SACCHARIN - NO SORBITOL

NO ASPARTAME - NO DYE

NO PHENYLPROPANOLAMINE

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 (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)

artificial flavor, citric acid, 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, 20mg

Guaifenesin, 400 mg

Phenylephrine HCl, 10 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information