LAXACIN- laxacin tablet 
DIRECT RX

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.

----------

LAXACIN

Docusate Sodium 50 mg

Sennosides 8.6 mg

Stool Softener

Laxative


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

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.

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

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

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

Drug Facts

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.

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

ther information


each tablet contains: calcium 20 mg, sodium 4 mg

keep lid tightly closed

store at room temperature in a dry place


nactive 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.


uestions? 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 9006


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

497


[Laxacin 10-18]

LAXACIN 
laxacin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-497(NDC:50488-0901)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DEXTROSE (UNII: IY9XDZ35W2)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G55
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-497-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/26/2018
Labeler - DIRECT RX (079254320)
Registrant - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-497)

Revised: 3/2018
Document Id: 838584ec-1cff-b130-e053-2a91aa0a70a1
Set id: 68526336-76bb-7eac-e053-2a91aa0a751e
Version: 1
Effective Time: 20180326
 
DIRECT RX