NDC 50991-626 Poly Hist Forte

Doxylamine Succinate And Phenylephrine Hydrochloride

NDC Product Code 50991-626

NDC Code: 50991-626

Proprietary Name: Poly Hist Forte What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Doxylamine Succinate And Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
POLY;216
Score: 2

NDC Code Structure

  • 50991 - Poly Pharmaceuticals, Inc.
    • 50991-626 - Poly Hist Forte

NDC 50991-626-01

Package Description: 100 TABLET in 1 BOTTLE

NDC 50991-626-02

Package Description: 12 BLISTER PACK in 1 CARTON > 1 TABLET in 1 BLISTER PACK

NDC Product Information

Poly Hist Forte with NDC 50991-626 is a a human over the counter drug product labeled by Poly Pharmaceuticals, Inc.. The generic name of Poly Hist Forte is doxylamine succinate and phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Poly Pharmaceuticals, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Poly Hist Forte Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DOXYLAMINE SUCCINATE 10.5 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Poly Pharmaceuticals, Inc.
Labeler Code: 50991
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Poly Hist Forte Product Label Images

Poly Hist Forte Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

(in each tablet)Doxylamine Succinate 10.5mg

(in each tablet)Phenylephrine HCl 10 mg

Purpose

Antihistamine

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

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.

* Please review the disclaimer below.

Previous Code
50991-579
Next Code
50991-723