FDA Label for Giltuss Cough And Cold

Other

Drug Facts

Other information

• store at room temperature 15°- 30°C (59° - 86°F)
• close cap tightlly
• SAVE CARTON FOR COMPLETE DRUG FACTS

Tamper evident: do not use if safety seal is broken or missing

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Otc - Active Ingredient

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 15 mg

Guaifenesin, 300 mg

Phenylephrine HCI, 10 mg

Otc - Purpose

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Indications & Usage

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

Otc - Do Not Use

Do not use if 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

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

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).

Otc - Stop Use

Stop use and ask a doctor if

• 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

These can 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 accident overdose, get medical or professional help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

• 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

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

Inactive Ingredient

Inactive ingredients Citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, 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.

Package Label.Principal Display Panel

MAXIMUM STRENGTH

GILTUSS^®

COUGH & COLD

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

• COUGH AND COLD
• CHEST CONGESTION
• LOOSENS PHLEGM AND MUCUS
• STUFFY NOSE
• NASAL CONGESTION
• SINUS PRESSURE

4 FL OZ (118 mL)

58552-130 - 58552 130