PLUSPHARMA STOOL SOFTENER- docusate sodium tablet, film coated

PlusPHARMA by

Drug Labeling and Warnings

PlusPHARMA by is a Otc medication manufactured, distributed, or labeled by Gemini Pharmaceuticals, Inc. dba Plus Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Docusate Sodium 100 mg

PURPOSE

Purpose

Stool softener

INDICATIONS & USAGE

Uses

• for relief of occasional constipation (irregularity)
• this product generally produces a bowel movement within 12 to 72 hours

WARNINGS

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 habits 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 longer than one week

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years and older:
• take 1 tablet as needed, not to exceed 3 tablets daily, or as directed by a doctor
• tablets may be swallowed whole or crushed and mixed with food
• children under 12 years: consult a doctor before use

STORAGE AND HANDLING

Other information

• each tablet contains: c alcium 40 mg, s odium 10 mg
• store at room temperature in a dry place

INACTIVE INGREDIENT

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, silica, sodium benzoate, stearic acid

QUESTIONS

Questions? If you have any questions or comments, or to report an adverse event, please contact (800)-795-9775.

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed By:

Plus Pharma

Commack, NY 11725

Manufactured in a GMP facility in the USA

PRINCIPAL DISPLAY PANEL

PlusPHARMA

NDC: 51645-750-01

DOCUSATE SODIUM 100 mg

Stool Softener

Relieves Occasional Constipation (Irregularity)

Crushable Tablets for Ease of Administration

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

*Compare to the Active Ingredient in Colace®

*Plus Pharma is not affiliated with the owner of the registered trademark Colace®

100 TABLETS 100 mg each

INGREDIENTS AND APPEARANCE

PLUSPHARMA  STOOL SOFTENER
docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51645-750
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (Round Biconvex with bisect)	Size	11mm
Flavor		Imprint Code	GPI;S1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51645-750-99	10 in 1 CARTON	03/27/2006	11/30/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51645-750-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006
3	NDC: 51645-750-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/27/2006

Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(51645-750)