FDA Label for Docusate Sodium
View Indications, Usage & Precautions
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Purpose
Stool softener
Uses
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 12 to 72 hours
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Directions
take with a glass of water
Adults and children 12 years and over | 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. |
Children 2 to under 12 years of age | 1 softgel daily |
children under 2 years of age | ask a doctor |
Other Information
- each softgel contains: sodium 5 mg
- store at room temperature 15°-30°C (59°-86°F)
- protect from excessive humidity
Inactive Ingredients
FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China
Principal Display Panel - Shipping Label
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 53345-008-01
IMPORTANT:
- Inspect immediately upon receipt.
- This is a bulk shipment, intended for further processing only.
- Protect from heat, humidity, and light. Do not refrigerate.
- 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 REPACKAGING
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 15000 Capsules
NDC. No : 53345-008-02
IMPORTANT:
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
* Please review the disclaimer below.