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DOCUSATE SODIUM 100mg Two-Tone

Medically reviewed on August 13, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
NDC Code: 53345-023

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 Two-Tone, Capsule, liquid filled

Drug Facts

Active ingredient (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours

Warnings

Do not use
  • if you are currently taking mineral oil, unless told to do so by a doctor 

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • 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

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 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

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 : 53345-023-01

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 REPACKING"

DOCUSATE SODIUM 100MG TWO-TONE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-023
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 
D&C RED NO. 33 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
ANHYDROUS CITRIC ACID 
Product Characteristics
Colorred, white (Two-Tone) Scoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint Code657
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-023-011 BAG (BAG) in 1 BOX
120000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/11/2014
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-023), ANALYSIS(53345-023)

 
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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