DOCUSATE SODIUM LIQUID- docusate sodium.50mg/5ml solution

Docusate Sodium Liquid by

Drug Labeling and Warnings

Docusate Sodium Liquid by is a Otc medication manufactured, distributed, or labeled by Aldama Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL-teaspoonful)

Docusate Sodium 50mg

Purpose

Stool Softener

Uses

• Relief of occasional constipation

Warnings

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

Do not use

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

Ask a doctor 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 a doctor if

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

If pregnant or breast-feeding

ask a doctor before use

Keep out of reach of children.

In case of overdose, seek medical assistance or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• follow dosing directions below or use as directed by a physician
• must be give in a 6 oz to 8 oz glass of mil 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 the be reduced according to individual response
• do not exceed recommende dose
• shake well before using

Other information

• TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
• store at room temperature between 20-25°C (68-77°F)
• Permitted excursions between 15-30°C (59-86°F)
• protect from excessive heat
• Pharmacist:: preserve and dispense in a tight light, light-resistant container with a child-resistant cap as defined in the UPS
• each teaspoon (5ml) contains sodium 5 mg

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Question or Comments?

305-592-9216 or info@aldamapharm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM LIQUID 
docusate sodium.50mg/5ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73564-813
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLOXAMER 124 (UNII: 1S66E28KXA)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73564-813-16	1 in 1 BOX	01/01/2026
1		473 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	01/01/2026

Labeler - Aldama Pharmaceuticals, Inc (119484030)

Establishment
Name	Address	ID/FEI	Business Operations
Aldama Pharmaceuticals, Inc		119484030	manufacture(73564-813)