LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet

Laxative Pills by

Drug Labeling and Warnings

Laxative Pills by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpose

Stimulant laxative

Uses

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

Warnings

Do not use

laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor. 

Ask a doctor before use if you have

• noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you

• are taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When using this product

• do not use for a period longer than 1 week

Stop use and ask a doctor if

• rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may 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

• swallow tablet(s) with a glass of water
• swallow tablet(s) whole, do not crush, break, or chew

• adults and children 12 years of age and older: take 2 tablets once or twice daily
• children 6 to under 12 years of age: take 1 tablet once or twice daily
• children under 6 years of age: ask a doctor

Other information

• each tablet contains: calcium 50 mg
• very low sodium
• store between 20-25ºC (68-77ºF)

Inactive ingredients

acacia, ammonium hydroxide*, calcium carbonate*, calcium phosphate dihydrate*, calcium sulfate anhydrous*, carnauba wax, corn starch*, croscarmellose sodium, dicalcium phosphate*, FD&C blue #1, hypromellose*, iron oxide*, iron oxide black, iron oxide yellow*, isopropyl alcohol*, kaolin*, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil*, n-butyl alcohol*, polyethylene glycol, polyvinyl alcohol*, povidone*, propylene glycol*, shellac*, silicon dioxide, sodium lauryl sulfate*, stearic acid, sucrose, talc, titanium dioxide, white wax*

*contains one or more of these ingredients

Questions or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

MAXIMUM STRENGTH

Laxative Pills

Sennosides USP, 25 mg

Stimulant Laxative Natural Senna Ingredient For Gentle, Dependable Overnight Relief

Compare To The Active Ingredients in ex-lax® Maximum Strength†

TABLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

†This product is not manufactured or distributed by GlaxoSmithKline pic, distributor of Ex-Lax®.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL ROAD,

MEMPHIS, TN 38118

www.fredsinc.com

Product Label

FRED"S Maximum Strength Laxative Pills

INGREDIENTS AND APPEARANCE

LAXATIVE PILLS  MAXIMUM STRENGTH
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-492
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
AMMONIA (UNII: 5138Q19F1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-492-03	1 in 1 BOX	01/31/2016
1		24 in 1 BOTTLE, PLASTIC; 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	01/31/2016

Labeler - Freds Inc (005866116)