LAXA-BASIC 100- docusate sodium capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)

Available from:

Basic Drugs, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Stool Softener Laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in 12 to 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
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 SODI