Dosage and administration
-adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor -children under 12 years of age: take as directed by a doctor
-adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor -children under 12 years of age: take as directed by a doctor
Store at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F)
Docusate Calcium
Stool Softener
for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.
-Do not use if you are currently taking mineral oil, unless directed by a doctor
-When abdominal pain, nausea, or vomiting are present
-For longer than 1 week, unless directed by a doctor
You notice a sudden change in bowel habits that persists over a period of 2 weeks.
You notice a sudden change in bowel habits that persists over a period of 2 weeks.
-You have rectal bleeding
-you fail to have a bowel movement after use
Ask a health care professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
-adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
-children under 12 years of age: take as directed by a doctor
-do not use if imprinted safety seal under cap is broken or missing
-This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak Stool Softener
Store at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F)
Corn oil, D&C Red #33, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.
Adverse Drug Event Call: (800) 616-2471
Distributed by: Rugby Laboratories, Inc. Duluth GA 30097
Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-980-07 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b6c-48b1-e053-8cdaa90a720a | Docusate Calcium |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-980-07 | Docusate Calcium | 07 in 1 BOTTLE | CAPSULE | 07 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-980-07 | EA - Each | 21695-980 | 5259c913-3587-423c-89a2-e7b544ad1498 | 1 | 2012-07-24 |
| 0536-3755-01 | EA - Each | 0536-3755 | ecbcc8af-b3d3-49e5-b321-e3b36584fdd7 | 1 | 2012-07-24 |
| 0536-3755-05 | EA - Each | 0536-3755 | b8d3bfa9-e542-4c89-ace2-885d60aa9fa0 | 1 | 2012-07-24 |
| 0536-3755-10 | EA - Each | 0536-3755 | 93023aa5-4144-402c-a303-c47b5483447d | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DOCUSATE CALCIUM | ACTIVE INGREDIENT | 6K7YS503HC | 1 | |
| DOCUSATE | ACTIVE MOIETY | M7P27195AG | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 21695-980 | 21695-980-07 |
| 0536-3755 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOCUSATE CALCIUM | 6K7YS503HC | ACTIB |
| CORN OIL | 8470G57WFM | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
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 |
|---|---|---|---|---|---|---|
| f5480c36-4401-49f2-b550-912e01527ac8 | f5480c36-4401-49f2-b550-912e01527ac8 | 2011-09-07 | Warnings | f5480c36-4401-49f2-b550-912e01527ac8 f5480c36-4401-49f2-b550-912e01527ac8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.