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 Geritrex LLC, RIJ Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (per teaspoonful = 5 mL)

Docusate Sodium 50 mg

Purpose

Stool Softener

Uses

• prevents / relieves dry hard stool
• results usually occur 1 to 3 days after the first dose

Warnings

Do not use

• when abdominal pain, nausea, or vomiting are present
• 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 lasts more than 2 weeks

Stop use and ask a doctor if

• you have no bowel movement 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 health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions

• follow dosing directions below or take as directed by doctor
• must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
• may be taken as a single daily dose or in divided doses
• 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

• Adults and children 12 years and over: 1 to 6 teaspoons (50 to 300 mg)
• Children 2 to 12 years of age: 1 to 3 teaspoons (50 to 150 mg)

1 teaspoon = 5 mL

TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.

Other information

• Store at room temperature 15°-30°C (59°-86°F)
• protect from excessive heat
• Keep tightly closed
• Dispense in tight, light resistant container as defined in the USP
• each teaspoon (5 mL) contains: sodium 15 mg

Inactive ingredients

citric acid, D&C Red #33, flavor, methylparaben, parabens, poloxamer, polyethylene glycol 400, propylparaben, sodium citrate, sorbitol, sucrose, and water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM LIQUID 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-195
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
anhydrous citric acid (UNII: XF417D3PSL)
D&C red no. 33 (UNII: 9DBA0SBB0L)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
sodium citrate (UNII: 1Q73Q2JULR)
water (UNII: 059QF0KO0R)
Poloxamer 407 (UNII: TUF2IVW3M2)
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-195-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/28/2017

Labeler - Geritrex LLC (112796248)

Registrant - RIJ Pharmaceutical Corporation (144679156)