Dr. Sana®

Dr. Sana®
SPL v2
SPL
SPL Set ID 5fb2438b-8f2d-4af2-9981-42d278d26800
Route
ORAL
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Aloe Vera Leaf Citric Acid Monohydrate Caramel Eucalyptus Oil Ginger Glycerin Menthol, Unspecified Form Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-14

Description

Dextromethorphan HBr 20 mg Guaifenesin USP 200 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin USP 200 mg

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Section 42229-5

FORMULATED FOR DIABETICS

Helps Chest Congestion & Loosens Mucus

Aloe,

Ginger,

Eucalyptus.

SYRUP WITH

NATURAL

INGREDIENTS

• NO ALCOHOL • NO GLUTEN

Distributed by:

Healthtex Distributors, LLC

Miami, Florida 33142

[email protected]

Made in USA

TAMPER EVIDENT FEATURE: DO NOT USE THIS PRODUCT IF IMPRINTED CELLO-BAND OVER CAP IS TORN, BROKEN OR MISSING.

Section 50565-1

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

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 • A cough that is accompanied by excessive phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

Packaging

Drug Facts

Questions?

call Weekdays from 9:30 AM to 5 PM EST at Tel. 305-633-7900

Directions:

• do not exceed more than 6 doses in any 24-hour period

• shake well before use

• mL=milliliter

 age  dose
adults and children 12 years & more 2 tablespoons (30 mL) every 4 hours
children under 12 years of age consult your doctor

Other Information

• Each 30 ml contains: Sodium 4.8 mg

• Store Between 15°C to 30°C (59°F to 86°F)

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

Inactive Ingredients

Aloe Vera, Citric Acid, Caramel Color, Eucalyptus Oil, Ginger Root PE, Glycerin, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.

Active Ingredients: (in Each 30 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin USP 200 mg


Structured Label Content

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Section 42229-5 (42229-5)

FORMULATED FOR DIABETICS

Helps Chest Congestion & Loosens Mucus

Aloe,

Ginger,

Eucalyptus.

SYRUP WITH

NATURAL

INGREDIENTS

• NO ALCOHOL • NO GLUTEN

Distributed by:

Healthtex Distributors, LLC

Miami, Florida 33142

[email protected]

Made in USA

TAMPER EVIDENT FEATURE: DO NOT USE THIS PRODUCT IF IMPRINTED CELLO-BAND OVER CAP IS TORN, BROKEN OR MISSING.

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.

Purpose

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 • A cough that is accompanied by excessive phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

Packaging

Drug Facts

Questions?

call Weekdays from 9:30 AM to 5 PM EST at Tel. 305-633-7900

Directions:

• do not exceed more than 6 doses in any 24-hour period

• shake well before use

• mL=milliliter

 age  dose
adults and children 12 years & more 2 tablespoons (30 mL) every 4 hours
children under 12 years of age consult your doctor

Other Information (Other information)

• Each 30 ml contains: Sodium 4.8 mg

• Store Between 15°C to 30°C (59°F to 86°F)

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

Inactive Ingredients (Inactive ingredients)

Aloe Vera, Citric Acid, Caramel Color, Eucalyptus Oil, Ginger Root PE, Glycerin, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.

Active Ingredients: (in Each 30 Ml) (Active Ingredients: (in each 30 ml))

Dextromethorphan HBr 20 mg

Guaifenesin USP 200 mg


Advanced Ingredient Data


Raw Label Data

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