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

front back

POLY HIST FORTE
doxylamine succinate and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50991-216
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	7.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	blue	Score	2 pieces
Shape	OVAL (Caplet-Shaped)	Size	14mm
Flavor		Imprint Code	Poly;216
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50991-216-02	12 in 1 CARTON	10/01/2013	03/25/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:50991-216-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2013	03/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/01/2013	03/25/2020

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Name	Address	ID/FEI	Business Operations
Establishment
TG United, Inc.		172837085	manufacture(50991-216)

Revised: 3/2020

Document Id: a1b859df-c48d-579a-e053-2995a90a382f

Set id: 8f6622e1-b40d-4d1c-9322-463775728a25

Version: 7

Effective Time: 20200325

Poly Pharmaceuticals, Inc.