STOOL SOFTENER SYRUP- docusate sodium syrup

Stool Softener Syrup by

Drug Labeling and Warnings

Stool Softener Syrup by is a Otc medication manufactured, distributed, or labeled by AMERISOURCEBERGEN DRUG CORPORATION, GERI-CARE PHARMACEUTICAL CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL tablespoonful)

Docusate Sodium 60 mg

Purpose

Stool Softener Laxative

Uses

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

Warnings

Do not use for more than one week unless directed by a doctor

Ask a doctor before use if you

• have abdominal pain, nausea, or vomiting
• are taking mineral oil
• have noticed a sudden change in bowel habits that lasts more than 14 days
• have a sodium-restricted diet

Stop use and ask a doctor if

• you have rectal bleeding or failure to have a bowel movement within 3 days. 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 overdose, get medical help or contact a poison control Center right away.

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
• shake well before using

• Adults and children 12 years and over: 1 to 3 tablespoonfuls (15 to 45 mL)
• Children under 12 years of age: ask a doctor

Other information

• Each 15 mL tablespoonful contains: sodium 51 mg
• Store at room temperature 15°- 30° C (59°-86° F)
• protect from excessive heat
• Keep tightly closed

Inactive ingredients

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

package label

NDC: 46122-400-43

Compare to Colace® Syrup active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
SYRUP
Docusate Sodium
Relieves Constipation
60 mg/15 mL
16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

STOOL SOFTENER SYRUP 
docusate sodium syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-400
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: 46122-400-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2017	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/01/2017	09/30/2020

Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)