Label: DOCUSATE SODIUM AND SENNA - docusate sodium and sennosides tablet, film coated
- NDC Code(s): 0536-0355-01, 0536-0355-10
- Packager: Rugby Laboratories, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Active ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
- INDICATIONS & USAGE
- relieves occasional constipation
- generally produces bowel movement in 6-12 hours
- DO NOT USE
Do not use
- for longer than one week
- if you are taking mineral oil
- when abdominal pain, nausea or vomiting are present
- ASK DOCTOR
Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
- STOP USE
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after use of this product.
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
adults and children 12 years and over: 2-4 tablets once daily or in divided doses
children 6 to under 12 years: 1-2 tablets once daily or in divided doses
children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses
children under 2 years: ask a doctor
- STORAGE AND HANDLING
- each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
- store at 20°-25°C (68°-77°F)
- INACTIVE INGREDIENT
Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide
Questions or comments?
call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
- INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM AND SENNA
docusate sodium and senna tablet, film coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-0355 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg SENNOSIDES (SENNOSIDES) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 2 FD&C RED NO. 40 HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 SODIUM BENZOATE STEARIC ACID TITANIUM DIOXIDE Product Characteristics Color purple (burgundy) Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL;131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-0355-01 100 in 1 BOX 2 NDC:0536-0355-10 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/22/2011 Labeler - Rugby Laboratories, Inc (109178264) Registrant - Time Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time Cap Labs, Inc 037052099 manufacture