DOCUSATE SODIUM- docusate sodium liquid 
Safecor Health, LLC

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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SAFECOR HEALTH
Docusate Sodium Liquid
Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener

Use:

Relief of occasional constipation

WARNINGS:

Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor

Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. 

These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation

If pregnant or breast feeding, ask a health care professional before use.

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

Directions:

* Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
* Shake well before using
* Do not exceed recommended dose
* May be taken in one to four equally divided oral doses each day
* Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response

Adults and children 12 years of age and over5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor
Children 6 to 12 years of age4 mL to 15 mL (3 teaspoons) or as directed by a doctor
Children 3 to 6 years of age2 mL to 6 mL or as directed by a doctor
Children under 3 years of age1 mL to 4 mL or as directed by a doctor

1 teaspoon = 5 mL

Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions
between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified
water, sodium benzoate, sodium citrate, and sucralose.

NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204                                                   Rev: 11/2020 PN5473

3 4843322010 8

Principal Display Panel - Box Label

SAFECOR
HEALTH
Docusate Sodium Liquid
100 mg / 10 ml
Contains 40 (10 ml) Unit Dose Cups

See monograph for complete drug information.

NDC: 48433-220-40
QTY: 40
Lot: 21A0079
Exp: 2023-03-31

Store at room temperature 20°C-25°C (68°F-77°F);
excursions between 15°C-30°C (59°F-86°F) are allowed.
Protect from excessive heat. Protect from light.
This package design is not child resistant. For institutional use only.
Shake well before use.

3 48433 22040 5
Pkg By: Safecor Health, LLC Columbus, OH 43204
Questions or Comments: Call 1-800-447-1006

GTIN: 00348433220405
SN: 212802331
Exp; 2023-03-31
Lot 21A0079 PN5689.C

Principal Display Panel - Box Label

Principal Display Panel - Lid Label

Delivers 10 mL

NDC 48433-220-10

Docusate

Sodium Liquid

100 mg/10mL

SHAKE WELL

348433220108

Pkg By: Safecor Health, LLC

Columbus, OH 43204

PN5618.B

Principal Display Panel - Lid Label

DOCUSATE SODIUM 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-220(NDC:54859-813)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLOXAMER 124 (UNII: 1S66E28KXA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48433-220-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product09/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/01/2021
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675repack(48433-220)

Revised: 1/2023
Document Id: 2d0f2890-e03c-4adb-a45e-6f948f6cf030
Set id: efe4bf81-fb99-4755-aa23-4f8df5973be8
Version: 2
Effective Time: 20230110
 
Safecor Health, LLC