Laxative pills by The Kroger Co. DRUG FACTS

Drug Details [pdf]

LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet
The Kroger Co.

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

relief of occasional constipation (irregularity). This product generally produces a 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

Inactive ingredients

acacia, anhydrous lactose*, 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, isopropyl alcohol*, kaolin, lake brilliant blue FCF*, magnesium stearate, maltodextrin*, microcrystalline cellulose, Opacode Black S-1-17823*, Opagloss 6000P*, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, tartaric acid*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO active ingredient of Maximum Strength EX-LAX® **See side panel

25 mg Sennosides

Natural Senna Ingredient

Stimulant Laxative

Laxative Pills

MAXIMUM STRENGTH

For Gentle, Dependable Overnight Relief

TABLETS

TAMPER EVIDENT-USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

**Ex-Lax® is a registered trademark of Novartis Consumer Health, Inc., Parsippany, NJ 07054. Novartis Consumer Health, Inc. is not affiliated with The Kroger Co. or this product.

Distributed by The Kroger Co.

Cincinnati, Ohio 45202

Product Label

Kroger Laxative Pills Tablet

LAXATIVE PILLS MAXIMUM STRENGTH
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-014
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)
STARCH, CORN (UNII: O8232NY3SJ)
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)
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: 30142-014-24	2 in 1 CARTON	06/16/2013	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	06/16/2013	12/31/2019

Labeler - The Kroger Co. (006999528)

Revised: 12/2018

Document Id: 15f565a0-c0e7-4959-b9d7-629a9d010792

Set id: 266af027-6e20-473e-ab83-3afc31da7b3e

Version: 2

Effective Time: 20181218