Other
Drug Facts
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
Giltuss Diabetic Solution
FDA Label NDC 58552-134
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 Diabetic (NDC 58552-134). 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 other, otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - when using, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients (in each 10 mL)
Dextromethorphan HBr, 20 mg
Guaifenesin 200 mg
Otc - Purpose
Purposes
Cough Suppressant
Expectorant
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
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
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 MAOl drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - When Using
When using this product do not use more than directed
Otc - Ask Doctor
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 - Stop Use
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts 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 accidental overdose, get medical or professional help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
- do not take more than 6 doses in any 24-hour period
- keep dosing cup with product
- mL = milliliters
| Adults and children 12 years and over | 10 mL every 4 hours |
| children 6 to under 12 years of age | 5 mL every 4 hours |
| children 2 to under 6 years of age | 2.5 mL every 4 hours |
| children under 2 years of age | Do not use |
Storage And Handling
Other information
- store at room temperature, between 15°- 30°C (59°- 86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredient
Inactive ingredients: Citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water and sucralose.
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.
Other Safety Information
Tamper evident: do not use if safety seal is broken or missing.
PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING ANY MEDICATION OR DIETARY SUPPLEMENT
THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE DIABETES
Package Label.Principal Display Panel
Giltuss® DIABETIC
COUGH & COLD
RELIEVES
- COUGH AND COLD
- CHEST CONGESTION
- LIQUIFIES AND LOOSENS PHLEGM AND MUCUS
SAFE FOR PEOPLE WITH DIABETES
GRAPE FLAVOR
4 FL OZ (118 mL)
58552-134 (58552 134)
* Please review the disclaimer below.
