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.
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401S BASICS
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 7 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
• TAMPER EVIDENT: Do not use if imprinted seal
under cap is missing or broken.
INACTIVE INGREDIENTS
FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG,
sorbitol special,
water.
PACKAGE LABEL
LAXA-BASIC 100
docusate sodium capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0761-0434
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)
BASIC DRUGS, INC.
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C YELL