Pyrilamine Maleate and Phenylephrine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Pyrilamine Maleate and Phenylephrine Hydrochloride

Xspire Pharma LLC

Phenylephrine HCl and Pyrilamine Maleate TABLETS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients
(per tablet)
Purpose
Phenylephrine Hydrochloride 10 mg Nasal Decongestant
Pyrilamine Maleate 25 mg Antihistamine

Pyrilamine Maleate and Phenylephrine Hydrochloride Uses

Temporarily relieves

  • nasal congestion due to hay fever (allergic rhinitis)
  • runny nose
  • sneezing, itching of nose or throat and itchy, watery eyes due to hay fever
  • or upper respiratory allergies

Warnings

Do not exceed recommended dosage.

Do not use this product

  • 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 you prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.
  • Do not use for more than 3 days. Use only as directed. Frequent for prolonged use may cause nasal congestion to recur or worsen.

Ask a doctor before use if you have

  • heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlargement of the prostate gland, or if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma.

Ask a doctor before use if you are taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedative and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over 1 tablet every 4-6 hours, not to exceed 6 tablets in 24 hours
Children 6 to 12 years of age 1/2 tablet every 4-6 hours, not to exceed 3 tablets in 24 hours.
Children 6 years of age and younger: Consult a physician.

Other information:

store at controlled room temperature between 18°-30°C (50° - 86°F).

Supplied in a light, light-resistant container with a child-resistant cap

Phenylephrine HCI and Pyrilamine Maleate Tablets are blue, caplet-shaped, scored tablets, debossed “Poly” bisect “210” on one side and plain on the other.

Inactive ingredients

Blue #2 Al Lake, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose

Questions? Comments?

Call 1-601-990-9497

Manufactured for:
Xspire Pharma
Ridgeland, MS 39157

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 42195-210-10

PHENYLEPHRINE HCI
and PYRILAMINE
MALEATE TABLETS

Nasal Decongestant • Antihistimine

Each tablet contains:

Phenylephrine HCl ..................10 mg

Pyrilamine Maleate...................25 mg

100 Tablets

Manufactured for:
Xspire Pharma:
Ridgeland, MS 39157

Pyrilamine Maleate and Phenylephrine Hydrochloride

Pyrilamine Maleate and Phenylephrine Hydrochloride

Pyrilamine Maleate and Phenylephrine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42195-210
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PYRILAMINE MALEATE PYRILAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 2
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
BLUE 14 mm Poly;210 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42195-210-10 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-10-28


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Be sure to consult your doctor before taking any medication!
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