Indications and uses
• relieves occasional constipation (irregularity) • This product generally produces bowel movement in 6 to 12 hours.
• relieves occasional constipation (irregularity) • This product generally produces bowel movement in 6 to 12 hours.
• take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. age dosage adults and children 12 years and older take 2-4 tablets daily children 6 to under 12 years take 1-2 tablets daily children 2 to under 6 years take up to 1 tablet daily children under 2 years Ask a doctor
• each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM • each tablet contains: calcium 20 mg/tablet Store at 25ºC (77ºF); excursions permitted to 15º - 30ºC (59°- 86°F). [See USP Controlled Room -Temperature]
Drug Facts
| Active ingredients (in each tablet) | Purposes |
|---|---|
Docusate sodium 50 mg | Stool softener |
Sennosides 8.6 mg | Stimulant laxative |
Each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
| Purposes | |
|---|---|
Docusate sodium 50 mg | Stool softener |
Sennosides 8.6 mg | Stimulant laxative |
Do Not Use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use
Stop use and ask a doctor if
These could be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use.
Keep this and all drugs out of the reach of children. In case of overodse, get medical help or contact a Poison Control Center right away.
| age | dosage |
|---|---|
adults and children 12 years and older | take 2-4 tablets daily |
children 6 to under 12 years | take 1-2 tablets daily |
children 2 to under 6 years | take up to 1 tablet daily |
children under 2 years | Ask a doctor |
Store at 25ºC (77ºF); excursions permitted to 15º - 30ºC (59°- 86°F). [See USP Controlled Room -Temperature]
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid and titanium dioxide.
To Report Serious Adverse Drug Event: (800) 616-2471
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N. Laurel Park Dr., Suite 233 • Livonia, MI 48152 USA
Distributed by:
Cardinal Health
Dublin, OH 43017
L37710941018
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5643-60 | EA - Each | 0904-5643 | 672627f1-a8ac-46c7-b78a-454c6773bfdf | 1 | 2013-02-11 |
| 0904-5643-61 | EA - Each | 0904-5643 | 4c34882b-7edf-4eca-adef-036c1f6224c3 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DOCUSATE SODIUM | ACTIVE INGREDIENT | F05Q2T2JA0 | 6 | |
| SENNOSIDES | ACTIVE INGREDIENT | 3FYP5M0IJX | 6 | |
| DOCUSATE | ACTIVE MOIETY | M7P27195AG | 6 | |
| SENNOSIDES | ACTIVE MOIETY | 3FYP5M0IJX | 6 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | 6 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 6 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55154-0733 | 55154-0733-0 |
| 0904-5643 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / RECTAL | 0.25 mg/mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / BUCCAL | 60 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 64 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUSPENSION / ORAL | 400 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAVENOUS | 24186 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION/ DROPS / OPHTHALMIC | 1 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPRAY, METERED / NASAL | 320 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / ORAL | 2240 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION, CONCENTRATE / ORAL | 2813 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LIQUID / TOPICAL | 1 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg |
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 |
|---|---|---|---|---|---|---|
| 662e7c8d-e386-49e5-ab90-71ecd2459edb | 8bb66fe4-e216-4fc2-b91c-500ded0a9624 | 2021-03-24 | Warnings | 8bb66fe4-e216-4fc2-b91c-500ded0a9624 |
Adverse event summaries are temporarily unavailable. Other product information remains available.