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DOCUSATE SODIUM by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Medically reviewed on Apr 9, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
NDC Code: 53345-008

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.

DOCUSATE SODIUM 100mg, Capsule, liquid filled

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

Warnings

Ask a doctor before use if you have

  • stomach pain, nausea or vomitting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are presently taking mineral oil

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

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.

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:

  1. Inspect immediately upon receipt.
  2. This is a bulk shipment, intended for further processing only.
  3. Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 15000 Capsules
NDC. No : 53345-008-02


IMPORTANT:

  1. Inspect immediate upon receipt.
  2. This is a bulk shipment, intended for further processing only.
  3. Protect from heat, humidity, and light. Do not refrigerate.
  4. Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-008
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
ANHYDROUS CITRIC ACID 
Product Characteristics
ColorredScoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint CodePC1
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-008-011 BAG in 1 BOX
120000 CAPSULE, LIQUID FILLED in 1 BAG
2NDC:53345-008-021 BAG in 1 BOX
215000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/15/2013
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-008), ANALYSIS(53345-008)

 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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