OTC Medication Information: Stimulant Laxative Enteric Coated

STIMULANT LAXATIVE ENTERIC COATED- bisacodyl tablet
Bryant Ranch Prepack

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use if you cannot swallow without chewing
Ask a doctor before use if you have
• stomach pain, nausea, vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product • do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness and cramps
Stop use and ask a doctor if • you have rectal bleeding or no
bowel movement after using this product.
These could be signs of a serious condition.
• you need to use a laxative for more than 1 week
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

  • take with a glass of water
  • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
  • children 12 and under: ask a doctor

Other information

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive humidity • package not child resistant

Inactive ingredients

acacia, ammonium hydroxide,
calcium carbonate, corn starch, D&C yellow #10 lake,
FD&C yellow #6 lake, hypromellose, iron oxide black, lactose,
magnesium stearate, methylparaben, PEG, polydextrose,
polyvinyl acetate phthalate, propylparaben, propylene glycol,
povidone, shellac, simethicone, silica, sodium alginate,
sodium benzoate, sodium bicarbonate, stearic acid, sucrose,
talc, titanium dioxide, triacetin, triethyl citrate, wax.

Questions or comments?

1-800-540-3765

HOW SUPPLIED

NDC: 71335-1531-0: 25 Tablets in a BOTTLE

NDC: 71335-1531-1: 30 Tablets in a BOTTLE

NDC: 71335-1531-2: 2 Tablets in a BOTTLE

NDC: 71335-1531-3: 3 Tablets in a BOTTLE

NDC: 71335-1531-4: 4 Tablets in a BOTTLE

NDC: 71335-1531-5: 10 Tablets in a BOTTLE

NDC: 71335-1531-6: 90 Tablets in a BOTTLE

NDC: 71335-1531-7: 8 Tablets in a BOTTLE

NDC: 71335-1531-8: 100 Tablets in a BOTTLE

NDC: 71335-1531-9: 20 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.Burbank, CA 91504

Bisacodyl 5mg Tablet

Label
(click image for full-size original)
STIMULANT LAXATIVE ENTERIC COATED bisacodyl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-1531(NDC:57896-441)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (DEACETYLBISACODYL) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM ALGINATE
SODIUM BENZOATE
SODIUM BICARBONATE
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
ACACIA
AMMONIA
CALCIUM CARBONATE
CARNAUBA WAX
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHYLPARABEN
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ACETATE PHTHALATE
PROPYLPARABEN
PROPYLENE GLYCOL
POVIDONE, UNSPECIFIED
SHELLAC
DIMETHICONE
SILICON DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-1531-0 25 TABLET in 1 BOTTLE None
2 NDC:71335-1531-1 30 TABLET in 1 BOTTLE None
3 NDC:71335-1531-2 2 TABLET in 1 BOTTLE None
4 NDC:71335-1531-3 3 TABLET in 1 BOTTLE None
5 NDC:71335-1531-4 4 TABLET in 1 BOTTLE None
6 NDC:71335-1531-5 10 TABLET in 1 BOTTLE None
7 NDC:71335-1531-6 90 TABLET in 1 BOTTLE None
8 NDC:71335-1531-7 8 TABLET in 1 BOTTLE None
9 NDC:71335-1531-8 100 TABLET in 1 BOTTLE None
10 NDC:71335-1531-9 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 01/01/2000
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-1531), RELABEL (71335-1531)

Revised: 01/2024 Bryant Ranch Prepack

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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