NDC 70518-1885 Sennosides,docusate Sodium

Sennosides,docusate Sodium

NDC Product Code 70518-1885

NDC Code: 70518-1885

Proprietary Name: Sennosides,docusate Sodium 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,docusate Sodium 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
CPC;490
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.
    • 70518-1885 - Sennosides,docusate Sodium

NDC 70518-1885-0

Package Description: 30 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Sennosides,docusate Sodium with NDC 70518-1885 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Sennosides,docusate Sodium is sennosides,docusate sodium. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Remedyrepack Inc.

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.

Sennosides,docusate Sodium 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 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.

  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • TALC (UNII: 7SEV7J4R1U)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

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: Remedyrepack Inc.
Labeler Code: 70518
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: 02-20-2019 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.

Sennosides,docusate Sodium Product Label Images

Sennosides,docusate Sodium 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

Drug Facts

Active ingredients (in each tablet) Sennosides 8.6 mgDocusate sodium 50 mg

Otc - Purpose

PurposesLaxativeStool softener

Uses

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

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.

Overdosage

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

Directions

  • Take preferably at bedtime or as directed by a doctor
  • Agestarting dosagemaximum dosageadults and children 12 years and over2 tablets once a day4 tablets twice a daychildren 6 to under 12 years1 tablets once a day2 tablets twice a daychildren 2 to under 6 years1/2 tablet once a day1 tablets twice a daychildren under 2 yearsask a doctorask a doctor

Other Information





each tablet contains: calcium 11 mg







each tablet contains: sodium 4 mg



■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredient

Croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake†, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin†contains FD&C yellow #5 lake (tartrazine) as a color additive.

Other

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING*Rugby Laboratories is not affiliated with the owner of the registered trademark Senokot-S.®Distributed by:



Rugby Laboratories17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152www.rugbylaboratories.com

* Please review the disclaimer below.

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