Label: STOOL SOFTENER- docusate sodium and sennosides tablet, coated
- NDC Code(s): 63548-4000-1
- Packager: Avema Pharma Solutions
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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 ingredients (in each tablet)
Docusate Sodium 50 mg*
Sennosides 8.6 mg**Close
relief of occasional constipation (irregularity). This product generally produces a bowel movement within 6 to 12 hours.Close
Ask a doctor before use if you have
- a sudden change in bowel habits that lasts over a period of 2 weeks
Stop use and ask a doctor if
- you need to use a laxative for more than 1 week
- you have no bowel movement or have rectal bleeding. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- doses may be taken as a single dose or in divided doses preferably in the evening
adults and children 12 years of age and older take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to 6 years of age take up to 1 tablet daily children under 2 years of age ask a doctor
- Other information
- each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
- each tablet contains: calcium 20 mg/tablet
- store at 15°-30°C (59°-86°F), protect from excessive moisture
- do not use if imprinted safety seal under cap is broken or missing
- *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Peri-Colace®.
- Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Red #40 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, sodium benzoate, stearic acid, and titanium dioxide. May also contain: ethanol, FD&C Blue # 2 Aluminum Lake, maltodextrin, mineral oil, Opadry ll Red, pregelatinized starch, silicon dioxide 50s.Close
- Package/Label Principal Display Panel
Compare to the active ingredients of Peri-Colace®*
STOOL SOFTENER PLUS STIMULANT LAXATIVE
DOCUSATE SODIUM, 50 MG
PLUS SENNOSIDES, 8.6 MG
For Relief of Occasional Constipation
- INGREDIENTS AND APPEARANCE
docusate sodium and sennosides tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-4000 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63548-4000-1 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/02/2010 Labeler - Avema Pharma Solutions (804087749)