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Stool softener laxative - Medication Information

Product NDC Code 36800-778
Drug Name

Stool softener laxative

Type Brand
Active Ingredients
Docusate sodium 100 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1115005
Application Number M007
Labeler Name TOP CARE (Topco Associates LLC)
Packages
Package NDC Code Description
36800-778-10 100 capsule, liquid filled in 1 bottle, plastic (36800-778-10)
36800-778-25 250 capsule, liquid filled in 1 bottle (36800-778-25)
36800-778-60 1 bottle, plastic in 1 box (36800-778-60) / 60 capsule, liquid filled 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 softgel) Docusate sodium 100 mg Purpose Stool softener laxative

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 only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor
adults and children 12 years and over take 1-3 softgels daily
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide *contains one or more of these ingredients

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 bowel movement in 12 to 72 hours

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Stool Softener Laxative DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITAN SORBITOL TITANIUM DIOXIDE P10;SCU2;D1

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 COMPARE TO THE COLACE® REGULAR STRENGTH STOOL SOFTENER ACTIVE INGREDIENT † Stool Softener DOCUSATE SODIUM, 100 mg LAXATIVE Gentle Dependable stimulant-Free SOFTGELS † This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® Regular Strength Stool Softener. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY TOPCO ASSOCIATED LLC ELK GROVE VILLAGE, IL 60007 [email protected] www.topcarebrand.com Product Labeling TOPCARE HEALTH Stool Softener Docusate Sodium 100 mg

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 lasts over 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 if you are presently taking mineral oil, unless told to do so 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? Call toll free 1-888-423-0139

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 could be signs of a serious condition. you need to use a laxative for more than 1 week

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 softgel contains : sodium 6 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

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 if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week 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

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