FDA Label for Phenagil Ch
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Phenagil Ch 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
Phenylephrine HCl 10 mg
Chlophedianol HCl 24 mg
Otc - Purpose
Purposes
Antihistamine
Nasal Decongestant
Cough Suppressant
Uses
Uses
Temporarily relieves runny nose and alleviates sneezing, itchy, watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.
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 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
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• persistent or chronic cough such as occurs with smoking, asthma
• chronic bronchitis, or emphysema
• excessive phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
• do not exceed recommended dose
• excitability may occur, especially in children
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
• nervousness, dizziness, or sleeplessness occurs
• symptoms do not improve within 7 days or occur with a fever
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache
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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Adults and Children 12 years of age and over: | take 1 tablet every 6 hours. Do not exceed 4 tablets in 24 hours |
Children 6 to under 12 years of age: | take 1/2 tablet every 6 hours as needed. Do not exceed 2 tablets in 24 hours |
Children under 6 years of age: | Consult a physician. |
Other Information
• store at room temperature, USP
• do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredient
Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.
Otc - Questions
Questions? Call 787-848-9114
Manufactured for: GIL PHARMACEUTICAL CORP.
Ponce, Puerto Rico 00716
Package Label.Principal Display Panel
NDC 58552-323-01
PHENAGIL® CH
ANTIHISTAMINE, NASAL DECONGESTANT AND ANTITUSSIVE
SUGAR FREE AND DYE FREE
Each tablet contains:
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCI 10 mg
Chlophedianol HCl 24 mg
100 Tablets
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00716
* Please review the disclaimer below.