DOCUSATE SODIUM by LLC Federal Solutions / Safecor Health, LLC

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by LLC Federal Solutions, Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCUSATE SODIUM- docusate sodium liquid 
LLC Federal Solutions

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.

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Drug Facts

Active ingredient per 5 mL (1 teaspoon)
Docusate Sodium 50 mg

Purpose
Stool Softener Laxative

Use

  • For relief of  occasional constipation
  • generally produces bowel movement in 12-72 hours

Warnings

Do not use

  • if you are presently taking mineral oil
  • when abdominal pain, nausea, or vomiting are present
  • for longer than one week

Ask a doctor before use if you have
noticed a sudden change in bowel habits that lasts over two weeks.

Ask a doctor or pharmacist before use if you are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

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

  • may be taken once daily or in divided doses
  • give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

adults and children over 12                         5 to 35 mL (1 to 7 teaspoons)
children 6 to under 12                                5 to 15 mL (1 to 3 teaspoons)
children 2 to under 6                                  2.5 to 5 mL (1/2 to 1 teaspoon)
children under 2                                         ask a doctor

Other information

  • each teaspoon contains: sodium 5 mg
  • shake well before using
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • dispense contents in a tight, light resistant container as defined in the USP.

Inactive ingredients
D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions or comments?

  • Call 1-855-333-6337
  • To Report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801
Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

REV 105-00          07/2013



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-771-25
DOCUSATE SODIUM
250 mg / 25 mL
(DOCU LIQUID)
DELIVERS 25 mL
SHAKE WELL BEFORE USING
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132
Product Label

DOCUSATE SODIUM 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 24451-771(NDC: 50383-771)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLOXAMER 181 (UNII: 09Y8E6164A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorVANILLA (natural and artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 24451-771-25100 in 1 BOX08/08/201312/31/2019
125 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/08/201312/31/2019
Labeler - LLC Federal Solutions (965036895)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675repack(24451-771)

Revised: 1/2020
Document Id: 2debf5b4-aa03-4d19-bba8-2e36b4534ede
Set id: a8f7554c-eae7-44fb-ac66-a7d678bcb91a
Version: 2
Effective Time: 20200107
 
LLC Federal Solutions