PYRILAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE tablet

Pyrilamine Maleate and Phenylephrine Hydrochloride by

Drug Labeling and Warnings

Pyrilamine Maleate and Phenylephrine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Xspire Pharma LLC . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PYRILAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE 
pyrilamine maleate and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42195-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	Poly;210
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42195-210-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/28/2013

Labeler - Xspire Pharma LLC (078312042)