DOCUSATE CALCIUM 240 MG SODIUM FREE- docusate calcium capsule, liquid filled

Docusate Calcium 240 mg sodium free by

Drug Labeling and Warnings

Docusate Calcium 240 mg sodium free by is a Otc medication manufactured, distributed, or labeled by AvPAK. 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.
• Helps to prevent dry, hard stools.
• 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

if you notice a sudden change in bowel habits that persists over a period of two 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 overdose, get medical help or contact a Poison Control Center immediately.

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

Corn Oil, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Ink (Edible), Sorbitol Special.

Questions or Comments

Call 1-855-361-3993                 

Package/Label Principal Display Panel

NDC: 50268-266-15

AvKARE                    

DOCUSATE
CALCIUM
SODIUM-FREE
STOOL SOFTENER
240 mg Each
100 Softgels

USA
AV Rev. 05/16 (P)          

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

                                      

INGREDIENTS AND APPEARANCE

DOCUSATE CALCIUM 240 MG SODIUM FREE 
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-266(NDC:54629-640)
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
CORN OIL (UNII: 8470G57WFM)
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	15mm
Flavor		Imprint Code	NV02
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-266-15	50 in 1 BOX	05/17/2017
1	NDC: 50268-266-11	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/17/2017

Labeler - AvPAK (832926666)