DIOCTO- docusate sodium syrup

DIOCTO by

Drug Labeling and Warnings

DIOCTO by is a Otc medication manufactured, distributed, or labeled by GERI-CARE PHARMACEUTICAL CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per tablespoon = 15mL)

Docusate Sodium 60 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 assistance 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 daily dose until first bowel movement, then reduce dose according to individual response
• do not exceed recommended dose
  • shake well before using

• Adults and children 12 years and over: 1 to 3 tablespoons
• Children under 12 years of age: ask a doctor

1 tablespoon = 15 mL

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
• For institutional use only
• Each teaspoon (5 mL) contains sodium: 14mg.

Inactive ingredients

citric acid, D&C Red #33, FD&C Red#40, flavors, glycerin, propylene glycol, water, sodium citrate, sodium saccharin, sodium benzoate, sorbitol.

package label

INGREDIENTS AND APPEARANCE

DIOCTO 
docusate sodium syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-409
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	60 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	red	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-409-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2012	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/01/2012	09/30/2020

Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)