Docusate Sodium by Major Pharmaceuticals / Pharmaceutical Associates, Inc. DOCUSATE SODIUM liquid

Docusate Sodium by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

(in each 5 mL)
Docusate sodium 100 mg

Purpose

Stool softener

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative.  These could be signs of a serious condition.
• you need to use a stool softener laxative for more than 1 week
• rash occurs

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

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• Dose once daily
• take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.

• adults and children 12 years and older: 5 to 20 mL (1 to 4 teaspoonfuls)
• children 6 to under 12 years of age: 5 to 10 mL (1 to 2 teaspoonfuls)
• children 3 to under 6 years of age: 2.5 to 5 mL (1/2 to 1 teaspoonful)
• children under 3 years: ask a doctor

Other information

• Sodium content: 14 mg/5 mL
• Store at controlled room temperature, 20º to 25ºC (68º to 77ºF)
• Protect from freezing
• Protect from light
• Clear pink to purple colored, cherry-vanilla flavored liquid supplied in the following

NDC  0904-7279-66:  10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients:

artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol

Questions or comments?

Call 1-800-845-8210

Distributed by:

R06/22

MAJOR® PHARMACEUTICALS
Indianapolis, IN  46268

Principal Display Panel

MAJOR

NDC  0904-7279-66
Docusate Sodium Liquid

100 mg/10 mL
Stool Softener Laxative

F0935C100622

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7279
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
RED 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink (Clear pink to purple pink)	Score
Shape		Size
Flavor	CHERRY (Cherry-Vanilla)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7279-72	10 in 1 CASE	12/08/2022
1		10 in 1 TRAY
1	NDC: 0904-7279-66	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 Drug	M007	12/08/2022

Labeler - Major Pharmaceuticals (191427277)