Label: DOCUSATE CALCIUM- stool softener capsule, liquid filled
- NDC Code(s): 57896-424-01
- Packager: Geri-Care Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 30, 2017
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- Active ingredient (in each softgel)
Docusate Calcium 240 mgClose
Stool Softener LaxativeClose
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Ask a doctor before use if you
- have stomach pain, nausea, or vomiting
- have a sudden change in bowel habits that persists over a period of 2 weeks
- are presently taking mineral oil
Stop use and ask a doctor if
- you need to use a laxative longer than 1 week
- you have rectal bleeding or fail to have a bowel movement.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before
Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.
- Adults and children 12 years of age and older: take 1 softgel daily, or as recommended by your physician
- children under 12: consult a doctor
- do not exceed recommended dose
- Other information
- store at room temperature, 15°-30°C (59°-86°F)
- Package not child resistant
- Product of USA, Romania or Canada
- Inactive ingredients
corn oil, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, sorbitol special, water. May also contain D&C red #33.Close
- package Label
THE SENSIBLE CHOICE FOR PRICE AND HEALTH
240 mg each
Compare to active ingredient in surfak*
- INGREDIENTS AND APPEARANCE
stool softener capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-424 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM 240 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) MANNITOL (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CORN OIL (UNII: 8470G57WFM) Product Characteristics Color red Score no score Shape OVAL (capsule) Size 18mm Flavor Imprint Code SCU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-424-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2000 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)