Drug Facts
Active ingredient (in each 10 mL) Purpose
Dextromethorphan HBr. 30 mg .... Cough Suppresant
Giltuss Dm Syrup
FDA Label NDC 58552-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Giltuss Dm (NDC 58552-150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, indications & usage, warnings, otc - do not use, ask a doctor before use if you have, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & 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
Warnings
Warnings
Otc - Do Not Use
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.
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
Otc - When Using
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
- In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & 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
Storage And Handling
Other information
- store at room temperature 15°-30°c (59°-86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredient
Inactive ingredients
Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin.
Otc - Questions
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
Principal Display Panel
Giltuss DM High Blood Pressure - NDC 58552-150-04 - Bottle Label
Image Description (Glituss Dm Bottle Label)
Giltuss DM High Blood Pressure - NDC 58552-150-04 - Carton Label
Image Description (Glituss Dm Carton Label)
* Please review the disclaimer below.
