NDC 72789-134 Chlorpheniramine Maleate 4 Mg

Chlorpheniramine Maleate

NDC Product Code 72789-134

NDC CODE: 72789-134

Proprietary Name: Chlorpheniramine Maleate 4 Mg 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: Chlorpheniramine Maleate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
AP;016
Score: 1

NDC Code Structure

  • 72789 - Pd-rx Pharmaceuticals, Inc.

NDC 72789-134-24

Package Description: 24 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Chlorpheniramine Maleate 4 Mg with NDC 72789-134 is a a human over the counter drug product labeled by Pd-rx Pharmaceuticals, Inc.. The generic name of Chlorpheniramine Maleate 4 Mg is chlorpheniramine maleate. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1363309.

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.

Chlorpheniramine Maleate 4 Mg 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.


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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Pd-rx Pharmaceuticals, Inc.
Labeler Code: 72789
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: 11-01-2015 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)

Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[Read More]

* Please review the disclaimer below.

Chlorpheniramine Maleate 4 Mg Product Label Images

Chlorpheniramine Maleate 4 Mg 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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

* Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton®Distributed by:



Reliable 1 Laboratories LLC, Valley Stream, NY 11580www.reliable1labs.com

Active Ingredient (In Each Tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Warnings

  • Ask a doctor before use if you haveglaucomatrouble urinating due to enlarged prostate glanda breathing problem such as emphysema or chronic bronchitis

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

General Precautions

  • When using this productyou may get drowsyavoid alcoholic drinksalcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in childrenDrug Facts continued on back of label

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 (800)222-1222.

Directions

Adults and children 12 years and overtake 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hourschildren 6 years to under 12 yearstake 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hourschildren under 6 yearsdo not use

Other Information

  • Each tablet contains: calsium 40 mg
  • Store at 15°-30°C (59°-86°F)

Inactive Ingredients

Croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:runny nosesneezingitchy nose or throatitchy, watery eyes

16 How Supplied

Chlorpheniramine MaleateTablets are available as follows:4 mg: Yellow, round, scored tablet, debossed "heart”. Available in bottles of 24 tablets (NDC 72789-134-24)

* Please review the disclaimer below.