Label: DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled
- NDC Code(s): 53345-023-01
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Category: HUMAN OTC DRUG LABEL
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 August 11, 2014
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
Docusate Sodium 100 mgClose
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 12 to 72 hours
Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel movements that lasts over 2 weeks
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be signs of a serious condition.
- you need to use a stool softener laxative for more than 1 week
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
Adults and children 12 years of ages and over
take 1 to 3 softgels daily
Children 2 and under 12 years of age
take 1 softgel daily
children under 2 years of age
ask a doctor
- Other information
- each softgel contains: sodium 5 mg
- VERY LOW SODIUM
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- Inactive ingredients
D&C Red #33, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
- PRINCIPAL DISPLAY PANEL - Shipping Label
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 53345-023-01
- Inspect immediate upon receipt.
- This is a bulk shipment intended for further processing only.
- Protect from heat, humidity, and light. Do not refrigerate.
- Store at 15-30°C (59-86°F)
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
- INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM 100MG TWO-TONE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-023 Route of Administration ORAL 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) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color red, white (Two-Tone) Score no score Shape CAPSULE (OVAL) Size 13mm Flavor Imprint Code 657 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-023-01 1 in 1 BOX 1 20000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/11/2014 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(53345-023) , ANALYSIS(53345-023)