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Gentle laxative - Medication Information

Product NDC Code 79903-178
Drug Name

Gentle laxative

Type Brand
Pharm Class Increased Large Intestinal Motility [PE],
Stimulant Laxative [EPC],
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Active Ingredients
Bisacodyl 5 mg/1
Route ORAL
Dosage Form TABLET, DELAYED RELEASE
RxCUI drug identifier 308753
Application Number M007
Labeler Name Wal-Mart Stores Inc
Packages
Package NDC Code Description
79903-178-08 1 blister pack in 1 carton (79903-178-08) / 8 tablet, delayed release in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (In each tablet) Bisacodyl 5mg

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 with a glass of water adults and children 12 years and over: take 1 to 3 tablets in a single daily dose children 6 to under 12 years: take 1 tablet in a single daily dose children under 6 years: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acacia, carnauba wax, collodial silicon dioxide, corn starch, FD&C yellow #6, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polyvinyl acetate, shellac, sodium starch glycoale, stearic acid, talc, titanium dioxide, triacetin

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 for relief of occasional constipation and irregularity this product generally produces 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.
GENTLE LAXATIVE BISACODYL ACACIA ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN FD&C YELLOW NO. 6 METHACRYLIC ACID MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYVINYL ACETATE PHTHALATE SHELLAC SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN BISACODYL DEACETYLBISACODYL F

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.
DISPLAY PANEL Compare to Dulcolax® Laxative active ingredient* GENTLE LAXATIVE BISACODYL 5 mg Overnight Relief Gentle, dependable constipation relief Relief in 6-12 hours 8 TABLETS ENTERIC COATED Gentle Lax 8 ct

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.
Distributed by: Walmart Inc. Bentonville, AR 72716 Product of India *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

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 or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks

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 1(800) 222-1222.

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? 1-888-287-1915

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 no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week

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 chew or crush tablet(s) it may cause stomach discomfort, faintness and cramps do not use within 1 hour after taking an antacid or milk

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: magnesium 5 mg store at 25°C (77°F) , excursions permitted between 15-30°C (59-86°F) protect from excessive humidity

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 cannot swallow without chewing Ask a doctor before use if you have stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product do not chew or crush tablet(s) it may cause stomach discomfort, faintness and cramps do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. 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 1(800) 222-1222.

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