Indications and uses
relieves occasional constipation (irregularity) generally causes bowel movement in 6 to 12 hours
relieves occasional constipation (irregularity) generally causes bowel movement in 6 to 12 hours
take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years and older 2 tablets once a day 4 tablets twice a day 6 to under 12 years 1 tablet once a day 2 tablets twice a day children under 6 years ask a doctor ask a doctor
Store at 20º - 25ºC (68º - 77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF). [See USP Controlled Room Temperature]
TAMPER-EVIDENT: Do not use this product if imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
Drug Facts
Standardized Senna Concentrate, Sennosides 8.6 mg
Sodium Dioctylsulfosuccinate 50mg
| Purposes | |
|---|---|
| Standardized Senna Concentrate, Sennosides 8.6 mg | laxative |
| Sodium Dioctylsulfosuccinate 50 mg | Stool softener |
rectal bleeding or failure to have a bowel movement occurs after use of a laxative. These could be signs of a serious condition.
ask a health professional before use.
In case of overodse, get medical help or contact a Poison Control Center right away.
| age | starting dosage | maximum dosage |
|---|---|---|
| adults and children 12 years and older | 2 tablets once a day | 4 tablets twice a day |
| 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
| children under 6 years | ask a doctor | ask a doctor |
Store at 20º - 25ºC (68º - 77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF). [See USP Controlled Room Temperature]
Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow # 5 Lake**, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Sodium Lauryl Sulfate, Starch, Stearic Acid, Titanium Dioxide and Triacetin.
**Warning: Contains FD&C Yellow #5 Lake (Tartrazone) as a color additive.
Adverse Drug Event Call (800) 616-2471
Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA
Re-Order No. 301557
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5512-52 | EA - Each | 0904-5512 | 20d61bdf-b11e-4f8b-9db0-7d3b83cbb7d3 | 1 | 2013-02-11 |
| 0904-5512-61 | EA - Each | 0904-5512 | 4a6495c4-71eb-4dd0-8405-6fc8d09074ab | 1 | 2013-02-13 |
| 0904-5512-80 | EA - Each | 0904-5512 | 5a94eafc-67ec-44d3-9345-15e866beded8 | 1 | 2013-02-11 |
| 0182-1113-01 | EA - Each | 0182-1113 | 9ca562b5-8cc9-496a-9976-3a2c1fde4872 | 1 | 2012-07-24 |
| 0182-1113-10 | EA - Each | 0182-1113 | f058ef60-b910-4848-b330-e102ef1a7807 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DOCUSATE SODIUM | ACTIVE INGREDIENT | F05Q2T2JA0 | 5 | |
| SENNOSIDES | ACTIVE INGREDIENT | 3FYP5M0IJX | 5 | |
| DOCUSATE | ACTIVE MOIETY | M7P27195AG | 5 | |
| SENNOSIDES | ACTIVE MOIETY | 3FYP5M0IJX | 5 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 5 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 5 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 5 | |
| MAGNESIUM SILICATE | INACTIVE INGREDIENT | 9B9691B2N9 | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 5 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 5 | |
| STARCH, TAPIOCA | INACTIVE INGREDIENT | 24SC3U704I | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 5 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0904-5512 | 0904-5512-61 |
| 0182-1113 |
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 |
|---|---|---|---|---|---|---|
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CONCENTRATE / ORAL | 20 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | CAPSULE, EXTENDED RELEASE / ORAL | 51 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, COATED / ORAL | 4.8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SHAMPOO, SUSPENSION / TOPICAL | 40 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GEL / TOPICAL | 0.05 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | SOLUTION / ORAL | 270 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SUSPENSION / ORAL | 6 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, COATED / ORAL | 488.7 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | AEROSOL, FOAM / TOPICAL | 240 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | WAFER / ORAL | 22 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / BUCCAL | 0.11 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OIL / AURICULAR (OTIC) | 419 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED / ORAL | 953 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, DELAYED RELEASE / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 3 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | POWDER, FOR SOLUTION / ORAL | 270 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | TABLET / SUBLINGUAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, COATED / ORAL | 7.93 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, COATED / ORAL | 29.03 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| 46a6b4cf-757c-4b86-b769-a772262f7d29 | 97e8f493-917f-4cf4-ac1c-badb7e5b33aa | 2019-12-12 | Warnings | 97e8f493-917f-4cf4-ac1c-badb7e5b33aa |
Adverse event summaries are temporarily unavailable. Other product information remains available.