POLY HIST FORTE- doxylamine succinate and phenylephrine hydrochloride tablet

Poly Hist Forte by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• 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.

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

INGREDIENTS AND APPEARANCE

POLY HIST FORTE 
doxylamine succinate and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-626
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	10.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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	CAPSULE	Size	14mm
Flavor		Imprint Code	Poly;216
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-626-02	12 in 1 CARTON	06/01/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50991-626-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2019

Labeler - Poly Pharmaceuticals, Inc. (198449894)