BICARSIM FORTE- simethicone tablet
KRAMER NOVIS

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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BICARSIM FORTE

Drug Facts

Active Ingredients (in each tablet)

Simethicone 125 mg

Purpose

Antiflatulent

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.

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.

ANTIFLATULENT

(antigas)

Manufactured in the USA for Kramer-Novis,

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

www.kramernovis.com

Packaging

Bicarsim Tablets

BICARSIM FORTE
simethicone tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52083-263-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2016	07/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	04/06/2016	07/31/2016

Labeler - KRAMER NOVIS (090158395)

Revised: 1/2021

Document Id: 6131d788-1492-44e2-bd65-067ea949c5cf

Set id: d32782b4-44bf-48b7-a540-b34715780e81

Version: 2

Effective Time: 20210108

KRAMER NOVIS