Giltuss Cough & Cold
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL)
Dextromethorphan HBr, 15 mg
Guaifenesin, 300 mg
Phenylephrine HCI, 10 mg
OTC - PURPOSE SECTION
Purposes
Cough Suppressant
Expectorant
Nasal Decongestant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
- temporarily relieves nasal congestion due to a cold
Warnings
OTC - DO NOT USE SECTION
Do not useif you are 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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor
- a cough with too much phlegm (mucus)
- a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).
OTC - STOP USE SECTION
Stop use and ask a doctor if
These can be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of accident overdose, get medical or professional help or contact a Poison Control Center immediately.
DOSAGE & ADMINISTRATION SECTION
Directions
| adults and children 12 years & over | 5 mL every 4 hours |
| children 6 to under 12 years of age | 2.5 mL every 4 hours |
| children 2 to 6 years of age | 1.25 mL every 4 hours |
| children under 2 years of age | Consult a doctor |
- do not exceed recommended dosage
- do not take more than 6 doses in any 24 hour period
- keep dosing cup for use with this product
- mL = milliliters
SPL UNCLASSIFIED SECTION
Other information
- store at room temperature 15°- 30°C (59° - 86°F)
- close cap tightlly
- SAVE CARTON FOR COMPLETE DRUG FACTS
INACTIVE INGREDIENT SECTION
Inactive ingredientsCitric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.
OTC - QUESTIONS SECTION
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.
SPL UNCLASSIFIED SECTION
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH
GILTUSS®
COUGH & COLD
ALCOHOL FREE. SUGAR FREE. DYE FREE
RELIEVES
4 FL OZ (118 mL)
- COUGH AND COLD
- CHEST CONGESTION
- LOOSENS PHLEGM AND MUCUS
- STUFFY NOSE
- NASAL CONGESTION
- SINUS PRESSURE