FDA Label for Phenagil
View Indications, Usage & Precautions
Phenagil 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 ingredients
(in each tablet)
Chlorpheniramine maleate 3.5 mg
Dextromethorphan HBr 29 mg
Phenylephrine HCI 10 mg
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
Uses
Temporarily relieves:
• cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
• nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
• runny nose.
• sneezing.
• itchy, watery eyes.
• itching of the nose or throat.
• temporarily restores freer breathing through the nose.
Warnings
Do not use
• to sedate a child or to make a child sleepy.
• 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.
Ask A Doctor Before Use If You Have
• heart disease.
• high blood pressure.
• thyroid disease.
• diabetes.
• trouble urinating due to an enlarged prostate gland.
• glaucoma.
• cough that occurs with too much phlegm (mucus).
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Ask A Doctor Or Pharmacist Before Use If You Are
• taking sedatives or tranquilizers.
• taking any other oral nasal decongestant or stimulant.
When Using This Product
• do not use more than directed.
• may cause drowsiness.
• avoid alcoholic beverages.
• alcohol, sedatives, and tranquilizers may increase drowsiness.
• be careful when driving a motor vehicle or operating machinery.
• excitability may occur, especially in children.
Stop Use And Ask A Doctor If
• you get nervous, dizzy, or sleepless.
• symptoms do not get better within 7 days or are accompanied by fever.
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Directions
•
Adults and Children 12 years and over.: Take one tablet every 6-8 hours.
Do not take more than 4 tablets in a 24 hour period.
•
Children 6 to 12 years of age: Take 1/2 tablet every 6-8 hours.
Do not take more than 2 tablets in a 24 hour period.
•
Children under 6 years: Consult a doctor.
Other Information
• store at room temperature.
• do not use if safety seal is broken or missing.
Inactive Ingredients
Hydroxypropyl Methylcellulose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate and Polyethylene Glycol.
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.
MANUFACTURED FOR:
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00716
Label revised: 04/22
Package Label.Principal Display Panel
PHENAGIL ® CH - NDC 58552-337-01 - 100's Bottle Label.
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