PYRILAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE- pyrilamine maleate and phenylephrine hydrochloride tablet 
Xspire Pharma LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Phenylephrine HCl and Pyrilamine Maleate TABLETS

Drug Facts

Active Ingredients
(per tablet)
Purpose
Phenylephrine Hydrochloride 10 mgNasal Decongestant
Pyrilamine Maleate 25 mgAntihistamine

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 age1/2 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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
PYRILAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE 
pyrilamine maleate and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42195-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScore2 pieces
ShapeCAPSULESize14mm
FlavorImprint Code Poly;210
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42195-210-10100 in 1 BOTTLE; Type 0: Not a Combination Product10/28/201312/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/28/201312/31/2020
Labeler - Xspire Pharma LLC (078312042)

Revised: 1/2021
 
Xspire Pharma LLC