NDC 68210-4101 Valumeds Natural Laxative

Sennosides

NDC Product Code 68210-4101

NDC CODE: 68210-4101

Proprietary Name: Valumeds Natural Laxative 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: Sennosides 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.

  • Sennosides are used to treat constipation. They may also be used to clean out the intestines before a bowel examination/surgery. Sennosides are known as stimulant laxatives. They work by keeping water in the intestines, which causes movement of the intestines.

Product Characteristics

Color(s):
BROWN (C48332)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
S8
Score: 1

NDC Code Structure

  • 68210 - Spirit Pharmaceuticals Llc

NDC 68210-4101-1

Package Description: 75 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Valumeds Natural Laxative with NDC 68210-4101 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Valumeds Natural Laxative is sennosides. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Valumeds Natural Laxative 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.

  • SENNOSIDES 8.6 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Spirit Pharmaceuticals Llc
Labeler Code: 68210
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: 07-02-2020 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: 12-31-2021 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.

Valumeds Natural Laxative Product Label Images

Valumeds Natural Laxative 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 Ingredient (In Each Tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

  • Relieves occasional constipation (irregularity)generally produces bowel movement in 6-12 hours

Do Not Use

  • Laxative products for longer than 1 week, unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Stomach painnauseavomitingnoticed a sudden change in bowel habits that lasts over 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. (1800-222-1222)

Directions

  • Take preferably at bedtime or as directed by a doctorAgeStarting DosageMaximum Dosageadults and children 12 years of age or over2 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

Other Information

  • Each tablet contains:
  • Calcium 24 mg and sodium 3 mgstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, maltodextrin, purified water, sodium lauryl sulphate, stearic acid

Pdp

Cabinet:LaxativeSennosides 8.6mg75 Tablets

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