Sign In

Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"

You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.

View Generic:
View Brand:

Topcare stool softener - Medication Information

Product NDC Code 76162-006
Drug Name

Topcare stool softener

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 TopCo Associates, LLC
Packages
Package NDC Code Description
76162-006-01 100 capsule, liquid filled in 1 bottle (76162-006-01)
76162-006-60 1 bottle in 1 carton (76162-006-60) / 60 capsule, liquid filled in 1 bottle
76162-006-81 400 capsule, liquid filled in 1 bottle (76162-006-81)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient(s) Docusate sodium 100mg

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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

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.
Use(s) 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

Spl product data elements

Usually a list of ingredients in a drug product.
Topcare Stool Softener Docusate Sodium DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL SOLUTION WATER PC18

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 Stool Softener Stool Softener Stool Softener Stool Softener

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other information each capsule contains: sodium 5mg VERY LOW SODIUM

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 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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 Call 1-888-952-0050 Monday through Friday 9am-5pm

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 stool softener laxative for more than 1 week

Pregnancy or breast feeding

Pregnancy or Breast feeding
Pregnancy/Breastfeeding ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Storage store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

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 a period of 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 stool softener laxative for more than 1 week Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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