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Vegetable laxative - Medication Information

Product NDC Code 63868-579
Drug Name

Vegetable laxative

Type Brand
Active Ingredients
Sennosides 8.6 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 312935
Application Number 505G(a)(3)
Labeler Name CHAIN DRUG MARKETING ASSOCIATION INC
Packages
Package NDC Code Description
63868-579-01 1 bottle, plastic in 1 carton (63868-579-01) / 100 tablet, film coated in 1 bottle, plastic
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Sennosides USP, 8.6 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
agestarting dosage maximum dosage
adults and children 12 years and over 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 6 to 12 hours

Purpose

Information about the drug product’s indications for use.
Purpose Stimulant laxative

Spl product data elements

Usually a list of ingredients in a drug product.
Vegetable Laxative Sennosides SENNOSIDES SENNOSIDES CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE light 44;298

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal display panel QC® QUALITY CHOICE NDC 63868-579-01 Compare to the Active Ingredient in Senokot®* Vegetable Laxative Sennosides USP, 8.6 mg Stimulant Laxative Vegetable Laxative Ingredient for Gentle Overnight Relief 100 Tablets Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®. 50844 REV1020C29812 100% QC S ATISFACTION GUARANTEED Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 Quality Choice 44-298 Quality Choice 44-298

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use laxative products for longer than 1 week unless directed by a doctor.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-800-426-9391

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not exceed recommended dosage.

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information each tablet contains: calcium 30 mg, sodium 1 mg Very Low Sodium store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from moisture see end flap for expiration date and lot number

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Do not use laxative products for longer than 1 week unless directed by a 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 When using this product do not exceed recommended dosage. 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API