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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Poly Hist Forte

Drug Facts

Active ingredients

(in each tablet)

Doxylamine Succinate 10.5mg

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:

Warnings

Do not exceed recommended dosage.

Do not use this product

Ask a doctor before use if you have

Ask a doctor before use if

you are taking sedatives or tranquilizers.

When using this product

Stop use and ask a doctor if

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.

Huntsville, AL Rev. 4/16

PRINCIPAL DISPLAY PANEL

NDC 50991-626-01

POLY HIST FORTE ®

TABLETS

Nasal Decongestant • Antihistamine

NEW FORMULA

Each tablet contains:

Doxylamine Succinate . . . 10.5 mg

Phenylephrine HCl . . . . . . 10 mg

100 Tablets

backlabel

POLY HIST FORTE 
doxylamine succinate and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-626
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE10.5 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
ShapeCAPSULESize14mm
FlavorImprint Code Poly;216
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-626-0212 in 1 CARTON06/01/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50991-626-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2019
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff2ffe0-e7cd-b361-e063-6294a90a5148
Set id: 8aa0015b-8fc1-7951-e053-2a95a90a8e72
Version: 5
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.