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| Product NDC Code | 70692-167 | ||||
|---|---|---|---|---|---|
| Drug Name | Good remedies gentle laxative |
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| Type | Brand | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, COATED | ||||
| RxCUI drug identifier | 308753 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Strive Pharmaceuticals Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Bisacodyl (USP) 5 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 • do not take more than directed • take with a glass of water adults and children 12 years of age and over 1 to 3 tablets in a single daily dose. It is recommended to start with the lowest dose (1 tablet) increasing the next day as needed children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years ask a doctor
| adults and children 12 years of age and over | 1 to 3 tablets in a single daily dose. It is recommended to start with the lowest dose (1 tablet) increasing the next day as needed |
| children 6 to under 12 years of age | 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 gum, calcium carbonate, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid co-polymer type C, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talcum, titanium dioxide, triethyl citrate
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 • for relief of occasional constipation and irregularity • this product generally produces bowel movement in 6-12 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.GOOD REMEDIES GENTLE Laxative Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA CALCIUM CARBONATE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ALUMINUM LAKE ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERYL MONOSTEARATE HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE RED MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE METHYLPARABEN SODIUM PROPYLPARABEN SODIUM SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE G
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.Packaging Strive-167
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.Drug Facts
Compare to the active ingredient of Dulcolax ® Laxative Tablets* Gentle, dependable constipation relief *This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax ® Laxative Tablets. READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY: Strive Pharmaceuticals, Inc. East Brunswick, NJ 08816 Product of India CT7069216752 REV.00-072023
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? 1-888-577-8033 Monday-Friday 8am - 4pm EST
Storage and handling
Information about safe storage and handling of the drug product.Other information • contains FD&C yellow no. 6 • store at 20°C- 25°C (68°-77°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 • it may cause stomach discomfort, faintness and cramps • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if • you have rectal bleeding or fail to have a 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.
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