NDC 61919-497 Laxacin

Laxacin

NDC Product Code 61919-497

NDC CODE: 61919-497

Proprietary Name: Laxacin 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: Laxacin 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.

  • This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.
  • This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
G55
Score: 1

NDC Code Structure

NDC 61919-497-60

Package Description: 60 TABLET in 1 BOTTLE

NDC 61919-497-71

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Laxacin with NDC 61919-497 is a a human over the counter drug product labeled by Direct Rx. The generic name of Laxacin is laxacin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Direct Rx

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.

Laxacin 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.

  • DOCUSATE SODIUM 50 mg/1
  • SENNOSIDES A AND B 8.6 mg/1
  • SENNOSIDES A AND B 8.6 mg/1
  • DOCUSATE SODIUM 50 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.

  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

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.
  • 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: Direct Rx
Labeler Code: 61919
FDA Application Number: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-26-2018 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.

Information for Patients

Senna

Senna is pronounced as (sen' a)

Why is senna medication prescribed?
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medic...
[Read More]
Stool Softeners

Stool Softeners is
Why is stool softeners medication prescribed?
Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoid...
[Read More]

* Please review the disclaimer below.

Laxacin Product Label Images

Laxacin 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

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDrug FactsManufactured for:Alexso Inc.Los Angeles, CA 90064

Otc - Active Ingredient

Active ingredients (in each tablet)Docusate Sodium 50 mgSennosides 8.6 mg

Otc - Purpose

PurposesStool softenerLaxative

Indications & Usage

Uses•

relieves occasional constipation (irregularity)



generally produces a bowel movement in 6-12 hours

Warnings

Warnings

Otc - Do Not Use

Do not use•

if you are now taking mineral oil, unless directed by a doctor



laxative products for longer than 1 week unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have•

stomach pain



nausea



vomiting



noticed a sudden change in bowel habits that continues over a period of 2 weeks

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

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.

Dosage & Administration

Directions•

take preferably at bedtime or as directed by a doctor
agestarting dosemaximum doseadults and children 12years and older2 tablets once a day4 tablets twice a daychildren 6 to under 12 years1 tablet once a day2 tablets twice a daychildren 2 to under 6 years1/2 tablet once a day1 tablet twice a daychildren under 2 yearsask a doctorask a doctor

Storage And Handling

Other information•

each tablet contains: calcium 20 mg, sodium 4 mg



keep lid tightly closed



store at room temperature in a dry place

Inactive Ingredient

Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

Otc - Questions

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078

* Please review the disclaimer below.