Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours
• do not exceed 8 tablets in 24 hours Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor 4 tablets in the morning and 4 tablets at bedtime children under 12 years ask a doctor
each tablet contains: calcium 30 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at 20°C-25°C (68°F-77°F)
Sennosides 8.6 mg
Laxative
Do not use
for more than 1 week unless directed by a doctor.
Ask a doctor before use if you
• have abdominal pain, nausea or vomiting
• have 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 may indicate a serious condition.
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.
• do not exceed 8 tablets in 24 hours
| Age
| Starting Dose
| Maximum Dose
|
|---|---|---|
| adults and children 12 years of age and older
| 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
| 4 tablets in the morning and 4 tablets at bedtime
|
| children under 12 years
| ask a doctor
|
croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, silica, talc, triacetin
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-415-01 | EA - Each | 57896-415 | 35474003-2d89-4f7c-8b19-f04514fdecb3 | 1 | 2023-05-05 |
| 57896-415-10 | EA - Each | 57896-415 | c7308376-15ce-4e13-8ed0-5846bc0219d9 | 1 | 2023-04-07 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57896-415 | 57896-415-01, 57896-415-10, 57896-415-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| SENNOSIDES | 3FYP5M0IJX | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 21f02bbe-f26b-9210-e063-6394a90a2ba5 | f0e78c77-8896-5f2b-e053-2a95a90af2e8 | 2024-09-12 | Warnings | 21f02bbe-f26b-9210-e063-6394a90a2ba5 f0e78c77-8896-5f2b-e053-2a95a90af2e8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.