BISACODYL 5MG- bisacodyl 5mg tablet, coated

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

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Active ingredient:
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)
Available from:
Allegiant Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stimulant Laxative - for relief of occasional constipation (irregularity) - this product generally produces bowel movement in 6 to 12 hours
Authorization status:
OTC monograph not final
Authorization number:
69168-398-92

BISACODYL 5MG- bisacodyl 5mg tablet, coated

Allegiant Health

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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232 - Health A2Z Womans Laxative

Active Ingredient (in each tablet)

Bisacodyl USP 5mg

Purpos e

Stimulant Laxative

Us es

for relief of occasional constipation (irregularity)

this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

if you are unable to swallow without chewing

within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

abdominal pain

nausea

vomiting

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

When using this product

do not chew or crush tablets

abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if

you need to use more than 1 week

rectal bleeding or failure to have a bowel movement after use of a laxative.

These may be signs of a serious condition.

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a doctor or

Poison Control Center (1-800-222-1222) right away.

Directions

take with water

Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily

Children 6 to 12 years of age: take 1 tablet once a day

Children under 6 years of age: consult a doctor

Other information

store between 68º to 77ºF (20º to 25ºC)

do not use blister unit is broken or torn

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch,

D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow # 6 aluminum lake,

hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polyvinyl

acetate pthalate, polydextrose, polyethylene glycol, propylparaben, propylene glycol, povidone, shellac

glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc,

titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

Bisacodyl 5mg Pink

BISACODYL 5MG

bisacodyl 5mg tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 16 8 -39 8

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISACO DYL (UNII: 10 X0 70 9 Y6 I) (DEACETYLBISACODYL - UNII:R0 9 0 78 E41Y)

BISACODYL

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACACIA (UNII: 5C540 3N26 O)

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

FD&C BLUE NO . 2 --ALUMINUM LAKE (UNII: 4AQJ3LG58 4)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

METHYLPARABEN (UNII: A2I8 C7HI9 T)

Po lyvinyl Aceta te Phtha la te (UNII: 58 QVG8 5GW3)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO L 10 0 0 (UNII: U0 76 Q6 Q6 21)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

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

SHELLAC (UNII: 46 N10 7B71O)

SO DIUM ALGINATE (UNII: C26 9 C4G2ZQ)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRO SE (UNII: C151H8 M554)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

Allegiant Health

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 9 16 8 -39 8 -

1 in 1 CARTON

12/23/20 14

1

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

Pro duc t

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

12/23/20 14

Labeler -

Allegiant Health (079501930)

Revised: 3/2019

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