Label: STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 55154-1876-3, 55154-1876-9
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 57896-401
- 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 (in each softgel)
Docusate Sodium 100 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 use.
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 and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor
• children under 12: consult a doctor
• do not exceed recommended doseClose
- Other information
• each softgel contains: sodium 5 mg. very low sodium
• store at 15°C-25°C(59° F-77° F)
• keep tightly closed
• product from USA or Canada
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.Close
- Inactive ingredients
FD and C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow #10, FD and C yellow #6 (sunset yellow), mannitol.
Compare to active ingredient in ColaceR*
*This product is not manufactured or distributed by the owner of the registered trademark ColaceR.
DIST. BY: GERI-CARE PHARMACUETICALS CORP.
1650 63rd Street, Brooklyn, NY 11204
Zanesville, OH 43701
- Principal Display Panel
100 mg SoftgelsClose
- Principal Display Panel
100 mg softgels
- Package Label
100 mg each
QTY 30 SoftgelsClose
- Card Label
100 mg eachClose
- INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1876(NDC:57896-401) 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 100 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color red (reddish) Score no score Shape OVAL Size 12mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-1876-9 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:55154-1876-3 28 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2000 Labeler - Cardinal Health (188557102) Registrant - Geri-Care Pharmaceutical Corp (611196254) Establishment Name Address ID/FEI Business Operations Cardinal Health 188557102 REPACK(55154-1876)