Giltuss ®
1a4fe686-3085-4543-bd6c-f20580b1df50
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each 10 mL) Purpose Dextromethorphan HBr. 30 mg .... Cough Suppresant
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
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
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
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
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
Warnings and Precautions (34071-1)
Warnings
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
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
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
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:00.238278 · Updated: 2026-03-14T23:12:59.392851