Pill Identifier App

← See all POLY HIST FORTE brands

POLY HIST FORTE by Poly Pharmaceuticals, Inc.

Dosage form: tablet
Ingredients: Phenylephrine Hydrochloride 10mg, Pyrilamine Maleate 25mg
Labeler: Poly Pharmaceuticals, Inc.
NDC Code: 50991-210

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.

POLY HIST FORTE TABLETS

Drug Facts Active ingredients
(in each tablet)
Phenylephrine
Hydrochloride 10 mg
Pyrilamine Maleate 25 mg

PurposeNasal Decongestant
Antihistamine

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • nasal congestion
  • reduces swelling of nasal passages
  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes

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 g 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 enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • 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, sedatives, 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 informationStore at controlled room temperature between 15°- 30°C (59°- 86°F).

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

Poly Hist Forte Tablets are blue, caplet-shaped, scored tablets, debossed "Poly" bisect "210" on one side and plain on the other.

Inactive ingredientscollodial silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #2 aluminum lake, magnesium stearate, and microcrystalline cellulose.

Questions? Comments?Call 1-800-882-1041

Manufactured for:
Poly Pharmaceuticals, Inc.
Quitman, MS  39355

                                                   Rev. 02/12



Product PackagingThe packaging below represents the labeling currently used:

Principal display panel and side panel for 100 Tablets label:

NDC 50991-210-01

POLY HIST FORTE®
TABLETS


Nasal Decongestant · Antihistamine

NEW FORMULA

Each tablet contains:
Phenylephrine HCl.................10 mg
Pyrilamine Maleate................25 mg

100 Tablets

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355


Usual Dosage:  See product foldout for full prescribing information.

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Store at controlled room temperature between 15°- 30°C (59°- 86°F).













POLY HIST FORTE 
phenylepherine hydrochloride, pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Pyrilamine Maleate (Pyrilamine) Pyrilamine Maleate25 mg
Inactive Ingredients
Ingredient NameStrength
Dibasic Calcium Phosphate Dihydrate 
Silicon dioxide 
Cellulose, Microcrystalline 
Croscarmellose Sodium 
Magnesium stearate 
Product Characteristics
ColorblueScore2 pieces
ShapeOVALSize14mm
FlavorImprint CodePoly;210
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-210-01100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/19/2011
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 09/2012
 
Poly Pharmaceuticals, Inc.

← See all POLY HIST FORTE brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)