Poly Hist Forte by Poly Pharmaceuticals, Inc. / TG United, Inc. Poly Hist Forte

Poly Hist Forte by

Drug Labeling and Warnings

Poly Hist Forte by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc., TG United, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POLY HIST FORTE- doxylamine succinate and phenylephrine hydrochloride tablet 
Poly Pharmaceuticals, Inc.

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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Poly Hist Forte

Drug Facts

Active ingredients      

(in each tablet)

Doxylamine Succinate 7.5mg      

Purpose

Antihistamine

Active ingredients

(in each tablet)

Phenylephrine HCl 10 mg            

Purpose

Nasal Decongestant

Uses

Temporarily 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 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 marked 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 hours, not to
exceed 6 tablets in 24 hours.
 Children 6 to 12 years of age:  1/2 tablet every 4 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 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 "216" on one side and plain on the other.

Inactive ingredients

FD&C Blue # 2, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions? Comments?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals, Inc.

Quitman, MS 39355       Rev. 9/13

PRINCIPAL DISPLAY PANEL

NDC: 50991-216-01

POLY HIST FORTE ®

TABLETS

Nasal Decongestant Antihistamine

NEW FORMULA

Each tablet contains:

Doxylamine Succinate . . . 7.5 mg

Phenylephrine HCl . . . . . . 10 mg

100 Tablets

frontback

POLY HIST FORTE 
doxylamine succinate and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50991-216
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE7.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorblueScore2 pieces
ShapeOVAL (Caplet-Shaped) Size14mm
FlavorImprint Code Poly;216
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50991-216-0212 in 1 CARTON10/01/201303/25/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 50991-216-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/201303/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/201303/25/2020
Labeler - Poly Pharmaceuticals, Inc. (198449894)
Establishment
NameAddressID/FEIBusiness Operations
TG United, Inc.172837085manufacture(50991-216)

Revised: 3/2020
 
Poly Pharmaceuticals, Inc.