LAXATIVE MAXIMUM STRENGTH- sennosides tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)
Available from:
EQUALINE (SuperValu)
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stimulant laxative - relieves occasional constipation (irregularity) - generally produces bowel movement in 6 to 12 hours
Authorization status:
OTC monograph not final
Authorization number:
41163-815-24, 41163-815-48

LAXATIVE MAXIMUM STRENGTH- sennosides tablet

EQUALINE (SuperValu)

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.

----------

Drug Facts

Active ingredient (in each tablet)

Sennosides USP, 25 mg

Purpos e

Stimulant laxative

Us es

relieves occasional constipation (irregularity)

generally produces bowel movement in 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 any other 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 Posion 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 40 mg

very low sodium

store between 20-25ºC (68-77ºF)

Inactive ingredients

acacia, calcium phosphate dihydrate, calcium sulfate anhydrous*, carnauba wax, corn starch*,

croscarmellose sodium, FD&C blue #1 aluminum lake, iron oxide*, iron oxide black, iron oxide

yellow*, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol,

povidone*, shellac, silicon dioxide*, stearic acid*, sugar, talc, titanium dioxide

Questions or comments?

Call toll free 1-877-932-7948

Principal Display Panel

compare to ex-lax® Maximum Strength active ingredient†

maximum strength

Laxative

Sennosides USP, 25 mg

(stimulant laxative)

gentle, dependable overnight relief

tablets

†This product is not manufactured or distributed by GlaxoSmithKline plc, distributor of ex-lax®

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRE, MN 55344 USA

Product Label

EQUALINE Maximum Streng th Laxative

LAXATIVE MAXIMUM STRENGTH

sennosides tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4116 3-8 15

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SENNO SIDES (UNII: 3FYP5M0 IJX) (SENNOSIDES - UNII:3FYP5M0 IJX)

SENNOSIDES

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACACIA (UNII: 5C540 3N26 O)

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

CALCIUM SULFATE ANHYDRO US (UNII: E9 34B3V59 H)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

KAO LIN (UNII: 24H4NWX5CO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRO SE (UNII: C151H8 M554)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

EQUALINE (SuperValu)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

TCL0 8 3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4116 3-8 15-24

24 in 1 CARTON

0 2/28 /20 19

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:4116 3-8 15-48

48 in 1 CARTON

0 2/28 /20 19

2

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part334

0 2/28 /20 19

Labeler -

EQUALINE (SuperValu) (006961411)

Revised: 3/2019

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