FDA Label for Giltuss Dm
View Indications, Usage & Precautions
Giltuss Dm Product Label
The following document was submitted to the FDA by the labeler of this product Gil Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each 10 mL) Purpose
Dextromethorphan HBr. 30 mg .... Cough Suppresant
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
Giltuss DM High Blood Pressure - NDC 58552-150-04 - Carton Label
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