PURGASOL- sennosides docusate sodium tablet

PURGASOL by

Drug Labeling and Warnings

PURGASOL by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purposes
Docusate sodium 50 mg	Stool softener
Sennosides 8.6 mg	Laxative

Uses

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

Warnings

Do not use

• this product if you are presently 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
• a sudden change in bowel movements that persists over 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 could be signs of 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 edad	starting dosage dosis inicial	maximum dosage dosis máxima
12 & over; 12 y más	2 tablets once a day; 2 tabletas una vez al día	4 tablets twice a day; 4 tabletas 2 veces al día
6-11	1 tablet once a day; 1 tableta una vez al día	2 tablets twice a day; 2 tabletas 2 veces al día
2-5	½ tablet once a day; ½ tableta una vez al día	1 tablet twice a day; 1 tableta 2 veces al día
Under 2; Menor de 2	ask a doctor; consulte con un médico	ask a doctor; consulte con un médico

Other information

• each tablet contains: calcium 20 mg, sodium 6 mg VERY LOW SODIUM
• store between 15°-30°C (59°-86°F)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Questions? ¿Preguntas?

1-800-858-3889

SPL UNCLASSIFIED SECTION

Distributed by / Distribuido por:
DLC Laboratories, Inc.
Paramount, CA 90723 USA

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton

PURGASOL®
Tablets

VEGETABLE LAXATIVE
AND STOOL SOFTENER
For Relief of Occasional
Constipation

Docusate sodium 50 mg / Sennosides 8.6 mg

SUGAR FREE!

60 Tablets

Gentle
Relief!

INGREDIENTS AND APPEARANCE

PURGASOL 
sennosides docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1552
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
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)

Product Characteristics
Color	orange (TCL081)	Score	no score
Shape	ROUND (TCL081)	Size	10mm
Flavor		Imprint Code	TCL081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1552-6	1 in 1 BOX	11/16/2009
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/16/2009

Labeler - DLC Laboratories, Inc. (093351930)