NDC 0536-1257 Triprolidine Hydrochloride

Triprolidine Hydrochloride

NDC Product Code 0536-1257

NDC 0536-1257-75

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Triprolidine Hydrochloride with NDC 0536-1257 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Triprolidine Hydrochloride is triprolidine hydrochloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Rugby Laboratories

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Triprolidine Hydrochloride 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.

  • TRIPROLIDINE HYDROCHLORIDE .938 mg/mL

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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.
  • 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: Rugby Laboratories
Labeler Code: 0536
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: 11-09-2019 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.

Triprolidine Hydrochloride Product Label Images

Triprolidine Hydrochloride 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

Purpose

(in each 1 mL dropperful)Triprolidine HCI 0.938 mg

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Ask A Doctor Before Use If You Have

■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis■ trouble urinating due to an enlarged prostate gland

Ask A Doctor Before Use If You Are

Taking sedatives or tranquilizers

When Using This Product

■ may cause drowsiness  ■ excitability may occur, especially in children■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect■ avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

■ new symptoms occur

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. (1-800-222-1222)

Directions

Do not exceed recommended dosage.■ use only with enclosed dropper■ do not use enclosed dropper for any other drug productAgeDoseadult and children 12 year of age or older:2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor.children 6 to under 12 years of age:1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) in 24 hours, or as directed by a doctor.children under
     
6 years of age:consult a doctor

Other Information

■ this packaging is child-resistant.■ store at room temperature 15°-30°C (59°-86°F)■ Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken

Inactive Ingredients

Bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose

* Please review the disclaimer below.