LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet
McKesson (Sunmark)

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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DRUG FACTS

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Uses

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

Warnings

Do not use

when abdominal pain, nausea, or vomiting are present
for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use. These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care 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

adults and children 12 years of age and older	take 2 tablets once or twice daily with a glass of water
children 6 to under 12 years of age	take 1 tablet once or twice daily with a glass of water
children under 6 years of age	consult a doctor

Other information

each tablet contains: calcium 40 mg/ tablet
each tablet contains: magnesium 10 mg/ tablet
each tablet contains: sodium 3 mg/ tablet VERY LOW SODIUM
store at 15º - 30ºC (59º-86ºF)
keep in a dry place
do not expose to excessive heat
*This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Ex-Lax®

Inactive ingredients

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 Aluminum Lake, iron oxide, iron oxide Black, iron oxide Yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, and titanium dioxide. May also contain: anhydrous lactose, isopropyl alcohol, Lake Brilliant Blue FCF, malto dextrin, Opacode Black S-1-17823, Opagloss 6000P, tartaric acid

Principal Display Panel

Compare to maximum strength EX-LAX® active ingredient*

laxative pills

maximum strength

for gentle, dependable overnight relief

25 mg- Sennosides tablets, USP

stimulant laxative

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

Questions or comments? Call toll free: 1-877-753-3935

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Product Label

Sennosides USP, 25 mg

LAXATIVE PILLS MAXIMUM STRENGTH
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-224
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	25 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TARTARIC ACID (UNII: W4888I119H)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL083;S25
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-224-04	2 in 1 CARTON	07/10/2010	12/31/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	07/10/2010	12/31/2019

Labeler - McKesson (Sunmark) (177667227)

Revised: 12/2018

Document Id: a471f3d5-bba3-41ae-af49-ef2b7764e646

Set id: f7b63376-0828-439b-94b0-f0b7be7390db

Version: 4

Effective Time: 20181228

McKesson (Sunmark)