giltuss ®

Drug Facts

Composition & Product

Active Ingredients

dextromethorphan (30 mg)

Inactive Ingredients

acesulfame potassium citric acid monohydrate raspberry glycerin menthol polyethylene glycol, unspecified povidone propylene glycol water sodium benzoate saccharin sodium

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2023-06-27

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

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* every 8 hours
Children under 4 years	Do not use

*use appropriate measuring syringe or measuring cup

Description

Active ingredient (in each 10 mL) Purpose Dextromethorphan HBr. 30 mg .... Cough Suppresant

Principal Display Panel

Giltuss DM High Blood Pressure - NDC 58552-150-04 - Bottle Label

Giltuss DM High Blood Pressure - NDC 58552-150-04 - Carton Label

Section 44425-7

Other information

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

Section 50565-1

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

Section 50566-9

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.

Section 50567-7

Section 50570-1

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 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.

Label revised: 02/23

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Section 53414-9

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

Drug Facts

Active ingredient (in each 10 mL) Purpose

Dextromethorphan HBr. 30 mg .... Cough Suppresant

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Indications and Usage (34067-9)

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

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* every 8 hours
Children under 4 years	Do not use

*use appropriate measuring syringe or measuring cup

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Giltuss DM High Blood Pressure - NDC 58552-150-04 - Bottle Label

Giltuss DM High Blood Pressure - NDC 58552-150-04 - Carton Label

Section 44425-7 (44425-7)

Other information

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

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

Section 50570-1 (50570-1)

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 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.

Label revised: 02/23

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Section 53414-9 (53414-9)

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

Drug Facts

Active ingredient (in each 10 mL) Purpose

Dextromethorphan HBr. 30 mg .... Cough Suppresant

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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