SENNALAX-S- senna and docusate sodium tablet, film coated

SennaLax-S by

Drug Labeling and Warnings

SennaLax-S by is a Otc medication manufactured, distributed, or labeled by Par Pharmaceutical, Sunrise Pharmaceutical Inc, Sunrise Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Docusate sodium, 50 mg
Sennosides, 8.6 mg

Purpose

Stool Softener
Stimulant laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

• laxative products for longer than 1 week unless told to do so by a doctor
• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dose	maximum dosage
adults & children 12 years and over	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 30 mg, sodium 3 mg VERY LOW SODIUM
• do not use if imprinted safety seal under cap is missing or damaged.
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
• keep tightly closed.

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

colloidal silicon dioxide, D&C yellow No. 10, dicalcium phosphate, ethanol, FD&C yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide.

SPL UNCLASSIFIED SECTION

Mfg. for:
Qualitest Pharmaceuticals
Huntsville, AL 35811

REV. 01/10

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNALAX-S 
senna and docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0603-0283
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 (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
ALCOHOL (UNII: 3K9958V90M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S90
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0603-0283-21	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2007	06/30/2020
2	NDC: 0603-0283-32	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2007	05/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	07/26/2007	06/30/2020

Labeler - Par Pharmaceutical (011103059)

Registrant - Sunrise Pharmaceutical Inc (168522378)

Establishment
Name	Address	ID/FEI	Business Operations
Sunrise Pharmaceutical Inc.		168522378	MANUFACTURE(0603-0283)