Label: DOCUSATE CALCIUM 240 MG SODIUM FREE- docusate calcium capsule, liquid filled
- NDC Code(s): 54629-640-01
- Packager: National Vitamin Company
- 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 June 29, 2016
If you are a consumer or patient please visit this version.
- Active ingredient
Docusate Calcium 240 mgClose
- For the relief of occasional constipation.
- Helps to prevent dry, hard stools.
- This product generally produces a bowel movement within 12 to 72 hours.
- Warnings: Do not use
- If you are currently taking mineral oil, unless directed by a doctor.
- When abdominal pain, nausea or vomiting are present.
- For longer than one week unless directed by a doctor.
- Ask a Doctor Before Use
if you notice a sudden change in bowel habits that persists over a period of two weeks.Close
- Stop Use and Ask a Doctor If
- You have rectal bleeding.
- You fail to have a bowel movement after use.
- If Pregnant or Breast Feeding
Ask a healthcare professional before use.Close
- Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center immediately.Close
Adults and Children over 12 years of age
Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.
Children under 12 years of age
Do not use this product for children under 12 years of age, unless directed by a doctor.Close
- Other Information
- Keep lid tightly closed.
- Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
- Do not use if either seal is broken or missing.
- Inactive Ingredients
Corn Oil, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Ink (Edible), Sorbitol Special.Close
- Questions or Comments
Call 1 (800) 682-9862Close
- Package/Label Principal Display Panel
240 mg Each
Manufactured and Distributed by
NATIONAL VITAMIN COMPANY
Casa Grande, AZ 85122
- INGREDIENTS AND APPEARANCE
DOCUSATE CALCIUM 240 MG SODIUM FREE
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54629-640 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 CORN OIL (UNII: 8470G57WFM) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color RED Score no score Shape OVAL Size 15mm Flavor Imprint Code NV02 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54629-640-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/01/2016 Labeler - National Vitamin Company (102098324) Registrant - National Vitamin Company (102098324) Establishment Name Address ID/FEI Business Operations National Vitamin Company 102098324 MANUFACTURE(54629-640) , ANALYSIS(54629-640)