LAXA-BASIC 100- docusate sodium capsule, liquid filled

Laxa-basic 100 by

Drug Labeling and Warnings

Laxa-basic 100 by is a Otc medication manufactured, distributed, or labeled by Basic Drugs, Inc., Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting
• have a sudden change in bowel habits that persists over a period of 2 weeks
• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week
• you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

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

• do not exceed recommended dose
• doses may be taken as a single daily dose or in divided doses.

• Adults and children 12 years and over: take 1-3 softgels daily
• Children 6 to under 12 years of age: take 1 softgel daily
• Children under 6: ask a doctor

Other information

• each softgel contains: sodium 5 mg. very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
• product from USA or Canada
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

Package Label

basic's

NDC# 0761-0414-20

Laxa-basic
100
Stool Softener

DOCUSATE SODIUM 100 mg

Basic DRUGS HIGH QUALITY BASICS

100 Softgels

INGREDIENTS AND APPEARANCE

LAXA-BASIC 100 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0761-0414
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	401
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0761-0414-20	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2012

Labeler - Basic Drugs, Inc. (052155082)

Registrant - Geri-Care Pharmaceutical Corp (611196254)