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Generic: phenylephrine hcl and chlorpheniramine maleate is used for the treatment of Urinary Bladder Neck Obstruction Duodenal Obstruction Infant, Newborn Infant, Premature Peptic Ulcer Prostatic Hyperplasia Rhinitis, Allergic, Perennial Status Asthmaticus Urticaria Glaucoma, Angle-Closure Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


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Drug Facts


Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg Phenylephrine HCl 10 mg

Otc - Purpose Section


Purposes Antihistamine Nasal Decongestant

Uses


Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • nasal congestion • itching of the nose or throat • sinus congestion and pressure

Warnings Section


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

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.

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 the reach of children.

OVERDOSAGE SECTION


In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and Children12 years of age and over: take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours
Children 6 to under 12 years of age: 1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period
Children under 6 years of age: Consult a physician.



Other Informaton


• store at room temperature, USP • do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredient Section


Magnesium Stearate, Microcrystalline Cellulose and Silica.

Otc - Questions Section


Questions? Call 787-848-9114 Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716

Package Label.principal Display Panel


NDC 58552-322-01 PHENAGIL

ANTIHISTAMINE AND NASAL DECONGESTANT

SUGAR FREE AND DYE FREE

Each tablet contains: Chlorpheniramine Maleate 3.5 mg Phenylephrine HCI 10 mg

100 Tablets

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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