LAXACIN- docusate sodium and sennosides tablet

Laxacin by

Drug Labeling and Warnings

Laxacin by is a Otc medication manufactured, distributed, or labeled by Alexso Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Purposes

Stool softener

Laxative

INDICATIONS & USAGE

Uses

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours

WARNINGS

Warnings

DO NOT USE

Do not use

• if you are now taking mineral oil, unless directed by a doctor
• laxative products for longer than 1 week unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that continues over a period of 2 weeks

STOP USE

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dose	maximum dose
adults and children 12 years and older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

STORAGE AND HANDLING

Other information

• each tablet contains: calcium 20 mg, sodium 4 mg
• keep lid tightly closed
• store at room temperature in a dry place

INACTIVE INGREDIENT

Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

QUESTIONS

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078

SPL UNCLASSIFIED SECTION

Manufactured for:

Alexso Inc.

Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC: 50488-0901-1

Laxacin

(laxastimucin)

Laxative Plus Stool Softener

Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each

Fast, Dependable Relief

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

100 Tablets

INGREDIENTS AND APPEARANCE

LAXACIN 
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-0901
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G55
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-0901-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/15/2018

Labeler - Alexso, Inc. (963338061)