Good Remedies Gentle Laxative Tablet, Coated
FDA Label NDC 70692-167
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Good Remedies Gentle Laxative (NDC 70692-167). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each tablet), purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Bisacodyl (USP) 5 mg
Purpose
Stimulant laxative
Use
• for relief of occasional constipation and irregularity • this product generally produces bowel movement in 6-12 hours
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
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 |
Other Information
• contains FD&C yellow no. 6
• store at 20°C- 25°C (68°-77°F)
• protect from excessive humidity
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
Questions Or Comments?
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Packaging
Strive-167 (7069216752)
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