Giltuss Diabetic Dm

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (30 mg)

Inactive Ingredients

Povidone Propylene Glycol Water Sodium Benzoate Saccharin Sodium Acesulfame Potassium Citric Acid Monohydrate Glycerin Menthol Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-08-09

Medication Information

Warnings and Precautions

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.
When using this product do not use more than directed.

Indications and Usage

Ask a doctor before use if you have

a cough with too much phlegm (mucus)
a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as these could be signs of a serious condition.

Dosage and Administration

Directions

do not exceed recommended dosage
do not take more than 4 doses in any 24-hour period
use enclosed dosing cup
mL= milliliter

Adults and children over 12 years	10 mL every 8 hours
Children under 6 years to under 12 years	5 mL every 8 hours
Children 4 years to under 6 years	2.5 mL use appropriate measuring syringe or measuring cup every 8 hours
Children under 4 years	Do not use

Description

Drug Facts Active Ingredient (In each 10 mL) Purpose Dextromethorphan HBr. 30 mg ......................... Cough Suppresant Uses temporarily relieves: cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Section 50565-1

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Section 51727-6

Inactive ingredients

Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin.

Section 53413-1

Questions or comments?

Call 1-787-848-9114,Monday-Friday 9AM-5PM EST.

Call your doctor for medical advice in the event of

side effects.

Section 55105-1

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

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

Section 55106-9

Drug Facts

Active Ingredient (In each 10 mL) Purpose

Dextromethorphan HBr. 30 mg ......................... Cough Suppresant

Uses

temporarily relieves:
- cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep

Section 60561-8

Other information

store at room temperature 15°-30°C (59°-86°F)
close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS

Principal Display Panel

Giltuss Diabetic DM - NDC 58552-149-04 - Bottle Label

Giltuss Diabetic DM - NDC 58552-149-04 - Carton Label

Structured Label Content

Indications and Usage (34067-9)

Ask a doctor before use if you have

a cough with too much phlegm (mucus)
a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as these could be signs of a serious condition.

Dosage and Administration (34068-7)

Directions

do not exceed recommended dosage
do not take more than 4 doses in any 24-hour period
use enclosed dosing cup
mL= milliliter

Adults and children over 12 years	10 mL every 8 hours
Children under 6 years to under 12 years	5 mL every 8 hours
Children 4 years to under 6 years	2.5 mL use appropriate measuring syringe or measuring cup every 8 hours
Children under 4 years	Do not use

Warnings and Precautions (34071-1)

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.
When using this product do not use more than directed.

Section 50565-1 (50565-1)

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Section 51727-6 (51727-6)

Inactive ingredients

Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin.

Section 53413-1 (53413-1)

Questions or comments?

Call 1-787-848-9114,Monday-Friday 9AM-5PM EST.

Call your doctor for medical advice in the event of

side effects.

Section 55105-1 (55105-1)

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

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

Section 55106-9 (55106-9)

Drug Facts

Active Ingredient (In each 10 mL) Purpose

Dextromethorphan HBr. 30 mg ......................... Cough Suppresant

Uses

temporarily relieves:
- cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep

Section 60561-8 (60561-8)

Other information

store at room temperature 15°-30°C (59°-86°F)
close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Giltuss Diabetic DM - NDC 58552-149-04 - Bottle Label

Giltuss Diabetic DM - NDC 58552-149-04 - Carton Label

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