Laxa-basic 100 by Basic Drugs, Inc. / Geri-Care Pharmaceutical Corp Basics 401 (408)

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]

LAXA-BASIC 100- docusate sodium capsule, liquid filled 
Basic Drugs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Basics 401 (408)

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

Package Label

LAXA-BASIC 100 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0761-0934
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	A92
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0761-0934-20	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2012	10/01/2022

Labeler - Basic Drugs, Inc. (052155082)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2021

Document Id: d22ed91d-fd4e-6f8a-e053-2995a90aae00

34390-5

Set id: b6852ce4-6f39-37b9-e053-2a95a90a0afa

Version: 2

Effective Time: 20211202