Laxacin Laxative Plus Stool Softener

Drug Details [pdf]

LAXACIN- docusate sodium and sennosides tablet
medsource pharmaceuticals

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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Laxacin

Laxative Plus Stool Softener

Active ingredient

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

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.

LOT#

Exp. Date:

Directions

take preferably at bedtime or as directly 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

Other information

Each tablet contains: Calcium 20 mg
Each tablet contains: Sodium 4 mg
Store at room temperature
Keep lid tightly closed in a dry place
Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

Croscarmellose Sodium, D&C Yellow #10, Dextrose, Dicalcium Phosphate, FD&C Yellow #6, Hypromelose, 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 (480) 253-9761.

Manufactured for:
Alexso Inc.
Thousand Oaks, CA 91360

Package/Label Principal Display Panel

pdp

LAXACIN
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45865-708(NDC: 50488-0901)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 45865-708-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	10/01/2011	12/31/2019

Labeler - medsource pharmaceuticals (833685915)

Name	Address	ID/FEI	Business Operations
Establishment
medsource pharmaceuticals		833685915	repack(45865-708)

Revised: 12/2018

Document Id: 7d77bb0b-6554-904d-e053-2a91aa0a5543

Set id: 7d77cad2-b2b1-c909-e053-2a91aa0a0473

Version: 2

Effective Time: 20181220

medsource pharmaceuticals