OTC Medication Information: Laxacin

LAXACIN- docusate sodium and sennosides a and b tablet
Alexso, 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.

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

Drug Facts

Active ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purposes

Stool softener

Laxative

Uses

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

Warnings

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 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 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.

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

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

Other information

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

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

Manufactured for:

Alexso Inc.

Los Angeles, CA 90064

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

Laxacin 10-18
(click image for full-size original)
LAXACIN
docusate sodium and sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-0901
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
DEXTROSE, UNSPECIFIED FORM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM BENZOATE
STEARIC ACID
TITANIUM DIOXIDE
SILICON DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 10mm
Flavor Imprint Code G55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50488-0901-1 100 TABLET in 1 BOTTLE None
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)

Revised: 02/2019 Alexso, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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