RITE AID STOOL SOFTENER- docusate calcium capsule, liquid filled

Rite Aid Stool Softener by

Drug Labeling and Warnings

Rite Aid Stool Softener by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Reese Pharmaceutical Co, Swiss Caps Romania. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Docusate Calcium 240 mg

Purpose

Stool Softener

Uses

• For the relief of occasional constipation.
• This product generally produces a bowel movement within 12 to 72 hours.

Warnings: Do not use

• If you are currently taking mineral oil, unless directed by a doctor.
• When abdominal pain, nausea or vomiting are present.
• For longer than one week unless directed by a doctor.

Ask a Doctor Before Use

■ 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.
• You fail to have a bowel movement after use.

If Pregnant or Breast Feeding

Ask a healthcare professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and Children over 12 years of age

Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

• Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
• Do not use if either seal is broken or missing.

Inactive Ingredients

FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Sorbitol Special.

Questions or Comments

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

RITE AID STOOL SOFTENER 
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-7810
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE CALCIUM	240 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	SCU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-7810-0	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/22/2021

Labeler - Rite Aid (014578892)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Caps Romania		565466997	manufacture(11822-7810)