Indications and uses
for overnight relief from occasional constipation (irregularity) generally produces bowel movement in 6-12 hours
Sennosides, Docusate Sodium
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2019-08-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:14:07
Label at a glance#
ProductSennosides, Docusate Sodium
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections
Dosage and administration
take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and older take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor
Contacts and useful links#
Websitewww.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
Drug Facts
Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
OTC - PURPOSE SECTION
Purposes
Stool softener
Stimulant laxative
Uses
- for overnight relief from occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
WARNINGS SECTION
OTC - DO NOT USE SECTION
Do not use
- laxative products for longer than one week, unless directed by a doctor
- if you are now taking mineral oil, unless directed by a doctor
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of two weeks
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and older | take 2-4 tablets daily |
children 6 to under 12 years of age | take 1-2 tablets daily |
children 2 to under 6 years of age | take up to 1 tablet daily |
children under 2 | ask a doctor |
Other information
- each tablet contains: calcium 11 mg
- each tablet contains: sodium 4 mg (VERY LOW SODIUM)
- store at 25°C (77°F); excursions permitted between 15º-30ºC (59º-86ºF)
INACTIVE INGREDIENT SECTION
croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin
Questions or comments?
1- 800-645-2158
SPL UNCLASSIFIED SECTION
*Rugby Laboratories is not afliated with the owner of the trademark Colace® 2-IN-1
SAVE CARTON FOR COMPLETE DRUG FACTS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: Sennosides, Docusate Sodium
GENERIC: Sennosides, Docusate Sodium
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-2288-0
COLOR: red
SHAPE: ROUND
SCORE: No score
SIZE: 10 mm
IMPRINT: CPC;490
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- DOCUSATE SODIUM 50mg in 1
- SENNOSIDES 8.6mg in 1
INACTIVE INGREDIENT(S):
- FD&C RED NO. 40
- LIGHT MINERAL OIL
- MAGNESIUM STEARATE
- SODIUM BENZOATE
- MALTODEXTRIN
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- HYPROMELLOSES
- STARCH, CORN
- TRIACETIN
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- SODIUM LAURYL SULFATE
- STEARIC ACID
- TALC
- CROSCARMELLOSE SODIUM
- FD&C YELLOW NO. 6
- FD&C BLUE NO. 1
- TITANIUM DIOXIDE
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Data Matrix | DUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRING | Remedy_Label.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1167-01 | EA - Each | 0536-1167 | 7ff3a8c9-8da0-49dd-9fde-57a73480aca4 | 1 | 2019-02-13 |
| 0536-1167-10 | EA - Each | 0536-1167 | 186b35ae-3428-4b3e-b637-17dd9bc0b315 | 1 | 2019-03-12 |
Products#
Every source-derived product name is available through these pages.
- Sennosides, Docusate Sodium
- SODIUM LAURYL SULFATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- STEARIC ACID
- TITANIUM DIOXIDE
- CROSCARMELLOSE SODIUM
- CROSCARMELLOSE
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- TALC
- STARCH, CORN
- SODIUM BENZOATE
- LIGHT MINERAL OIL
- MAGNESIUM STEARATE
- MALTODEXTRIN
- TRIACETIN
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- HYPROMELLOSES
- FD&C RED NO. 40
- DOCUSATE SODIUM
- DOCUSATE
- SENNOSIDES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-2288 | 70518-2288-0 |
| 0536-1167 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| b96c9556-ab9b-3040-e053-2a95a90a269c | 6973d747-0d8d-4f34-96af-d6f5e5a387ce | 2021-01-21 | Warnings | 6973d747-0d8d-4f34-96af-d6f5e5a387ce |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.