MAXIMUM STRENGTH LAXATIVE PILLS- sennosides tablet

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

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Active ingredient:
sennosides (UNII: 3FYP5M0IJX) (sennosides - UNII:3FYP5M0IJX)
Available from:
TARGET CORPORATION
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses: Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours
Authorization status:
OTC monograph not final
Authorization number:
11673-995-48

MAXIMUM STRENGTH LAXATIVE PILLS- sennosides tablet

TARGET CORPORATION

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.

----------

TARGET 195R - MAXIMUM STRENGTH LAXATIVE PILLS NDC 11673-995-48

ACTIVE INGREDIENT

Each Tablet contains:

CALCIUM SENNOSIDES 25 mg

INACTIVE INGREDIENTS

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose

sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide

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

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

PURPOSE

stool softener, laxative

Directions:

Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel

movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease

dose until you are comfortable.

Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets

twice a day

Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a

Children 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a

Children under 2 years - Ask a doctor

Uses:

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

CLOSE

WARNINGS:

Do not use this product

If you are presently taking mineral oil unless directed by a doctor

Laxative products for longer than 1 week unless directed by a doctor

Keep out of the reach of children. Incase of overdose, get medical help or contact a Poison Control

Center right away.

MAXIMUM STRENGTH LAXATIVE PILLS

sennosides tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:116 73-9 9 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

senno sides (UNII: 3FYP5M0 IJX) (senno sides - UNII:3FYP5M0 IJX)

se nno side s

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

KAO LIN (UNII: 24H4NWX5CO)

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

RAW SUGAR (UNII: 8 M70 7QY5GH)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

SHELLAC (UNII: 46 N10 7B71O)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

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

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

TALC (UNII: 7SEV7J4R1U)

ACACIA (UNII: 5C540 3N26 O)

Product Characteristics

Color

blue

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

TCL0 8 3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:116 73-9 9 5-48

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

0 4/26 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 4/0 9 /20 19

Labeler -

T ARGET CORPORAT ION (006961700)

Registrant -

T IME CAP LABORAT ORIES, INC. (037052099)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

TIME CAP LABORATORIES, INC.

0 370 520 9 9

ma nufa c ture (116 73-9 9 5)

TARGET CORPORATION

Revised: 4/2019

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