NDC 59556-896 Triprolidine Hydrochloride

Triprolidine Hydrochloride

NDC Product Code 59556-896

NDC 59556-896-59

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE

NDC 59556-896-89

Package Description: 1 BOTTLE in 1 CARTON > 50 mL in 1 BOTTLE

NDC Product Information

Triprolidine Hydrochloride with NDC 59556-896 is a a human over the counter drug product labeled by Strides Pharma Inc. The generic name of Triprolidine Hydrochloride is triprolidine hydrochloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Strides Pharma Inc

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 .625 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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)

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: Strides Pharma Inc
Labeler Code: 59556
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: 05-21-2019 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 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

Other

Drug Facts

Active Ingredients (In Each Ml)

Triprolidine HCl USP 0.625 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves:runny nosesneezingitching of nose and throatitchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

  • May cause excitability, especially in children

Do Not Use

  • If you or your children are taking sedatives or tranquilizers, without first consulting your doctorwith any other product containing triprolidine

Ask A Doctor Before Use If Your Child Has

  • Glaucomaa breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate gland

When Using This Product

  • Do not use more than directedmay cause drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If:

  • Nervousness, dizziness or sleeplessness occurssymptoms do not improve within 7 days or are accompanied by a fever

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take every 6 hoursdo not take more than 4 doses in 24 hours or as directed by a doctor.do not give more than directed or exceed the recommended daily dosageuse only enclosed dropperdo not use enclosed dropper for any other drug product Adults and children 12 years of age and over 4 mL (2.5 mg) Children 6 to under 12 years of age 2 mL (1.25 mg) Children under 6 years of age ask a doctor

Other Information

  • Store at controlled room temperature 15°-30°C (59°-86°F)Tamper Evident: Do not use if seal is broken or missing.

Inactive Ingredients

Bubble Gum Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions?

Call 1-877-244-9825

* Please review the disclaimer below.

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