FDA Label for Giltuss Diabetic Cough And Cold
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER SAFETY INFORMATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Giltuss Diabetic Cough And Cold 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.
Other
Drug Facts
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
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)
* Please review the disclaimer below.