BICARSIM FORTE- simethicone tablet

BICARSIM FORTE by

Drug Labeling and Warnings

BICARSIM FORTE by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each tablet)

Simethicone 125 mg

Purpose

Antiflatulent

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact poison control center immediately.

INDICATIONS & USAGE

Uses for relief of

bloating   pressure   fullness   stuffed feeling commonly referred to as gas

Warnings

 Do not exceed recommended dosage.

Stop use and ask a doctor if condition persists.

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

Directions

Take one tablet three times daily, preferably after meals. One tablet may be taken at bedtime to provide overnight relief.

• Adults: Swallow with water 1 tablet as needed after meals or at bedtime, not to exceed 4 tablets per day

Do not take more than 4 tablets in a 24 hour period unless directed by a doctor.

Inactive Ingredients

FD&C blue #1, FD&C blue #2, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium starch glycolate

Other Information

Store at controlled room temperature 15° -30°C (59° -86°F)

Tamper evident feature: Do not use if imprinted seal under cap is torn, broken or missing.

SPL UNCLASSIFIED SECTION

ANTIFLATULENT 

(antigas)

Manufactured in the USA for Kramer-Novis,

San Juan, PR 00917. T: (787) 767-2072.

www.kramernovis.com

Packaging

INGREDIENTS AND APPEARANCE

BICARSIM FORTE 
simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-263
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	KN263
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-263-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	04/06/2016

Labeler - KRAMER NOVIS (090158395)