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._
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BASICS 401
ACTIVE INGREDIENT (IN EACH SOFTGEL)
Docusate Sodium 100 mg
PURPOS E
Stool Softener Laxative
US ES
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
LAXA-BASIC 100
docusate sodium capsule, liquid filled
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 76 1-0 414
ROUTE OF ADMINISTRATION
ORAL
ACTIVE IN