DOCUSATE SODIUM LIQUID- docusate sodium liquid

Docusate Sodium Liquid by

Drug Labeling and Warnings

Docusate Sodium Liquid by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

PURPOSE

Purpose

Stool Softener

INDICATIONS & USAGE

Uses

Relief of occasional constipation

WARNINGS

Warnings

Do not use when

• abdominal pain, nausea, or vomiting are present unless directed by a doctor
• for more than one week unless directed by a doctor

Ask a doctore before use if you

• are taking mineral oil
• have noticed a sudden change in bowel habits that last more than two weeks

Stop use and ask doctor if

• you have no bowel movements within 3 days
• you have rectal bleeding
• these could be signs of a serious condition
• a skin rash occurs
• you experience throat irritation

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a doctor before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• follow dosing directions below or use as directed by a physician
• must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
• may be taken as a single daily dose or in dividend dose
• take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
• do not exceed recommended dose
• shake well before using

1 teasponnful = 5 mL

• Age: Dose
• Adults and children over 12 years of age: 1 to 6 teaspoons (50 mg - 300 mg)
• Children under 12 years of age: Ask a doctor

INACTIVE INGREDIENT

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

DISTRIBUTED BY 

ATLANTIC BIOLOGICALS CORP

MIAMI, FL 33179

QUESTIONS

Questions or comments? 1-800-645-2158

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM LIQUID 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-1304(NDC:0536-1304)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-1304-1	50 in 1 BOX, UNIT-DOSE	05/22/2023
1	NDC: 17856-1304-3	25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-1304-2	72 in 1 BOX, UNIT-DOSE	05/22/2023
2	NDC: 17856-1304-4	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/2020

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-1304)