QUALITY CHOICE STOOL SOFTENER- 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, Swiss Caps Romania. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-585
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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red, white (Two-Tone)	Score	no score
Shape	CAPSULE (OVAL)	Size	10mm
Flavor		Imprint Code	SCU2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-585-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2020
2	NDC: 63868-585-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/11/2020

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Reese Pharmaceutical (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Caps Romania		565466997	manufacture(63868-585)