QUALITY CHOICE STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

Quality Choice Stool Softener by

Drug Labeling and Warnings

Quality Choice Stool Softener by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Reese Pharmaceutical Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool softener

Uses

• relieves occasional constipation (irregularity)
• generally produces a 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 movements 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

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

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

• adults and children 12 years and over:

  take 1 to 3 softgels daily

• children 2 to under 12 years of age:

  take 1 softgel daily

• children under 2 years:

  ask a doctor

Other information

• each softgel contains: sodium 5 mg
• VERY LOW SODIUM
• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerol, Polyethylene glycol, purified water, sorbitol, titanium dioxide

Display Panel

INGREDIENTS AND APPEARANCE

QUALITY CHOICE STOOL SOFTENER  LAXATIVE
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-662
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red, white (Two-Tone)	Score	no score
Shape	CAPSULE (OVAL)	Size	20mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-662-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/19/2022

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Reese Pharmaceutical Company (004172052)