LAXACIN by DIRECT RX LAXACIN tablet

LAXACIN by

Drug Labeling and Warnings

LAXACIN by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Docusate Sodium 50 mg

Sennosides 8.6 mg

PURPOSE

Stool Softener

Laxative

INDICATIONS & USAGE

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.

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

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

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

Drug Facts

DO NOT USE

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

ASK DOCTOR

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.

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

ther information

each tablet contains: calcium 20 mg, sodium 4 mg

keep lid tightly closed

store at room temperature in a dry place

INACTIVE INGREDIENT

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.

QUESTIONS

uestions? 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 9006

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

[Laxacin 10-18]

INGREDIENTS AND APPEARANCE

LAXACIN 
laxacin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-497(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
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
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: 61919-497-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/26/2018

Labeler - DIRECT RX (079254320)

Registrant - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	repack(61919-497)