BICARSIM FORTE

Manufacturer
KRAMER NOVIS
Effective date
2016-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:21

Label at a glance#

ProductBICARSIM FORTE
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

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 .

Storage and handling

• 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.

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Uses for relief of

• bloating  • pressure  • fullness  • stuffed feeling commonly referred to as gas

Warnings

WARNINGS SECTION

• 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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Other Information

STORAGE AND HANDLING SECTION

• 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bicarsim TabletsBicarsim Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-263-60EA - Each52083-263890a5921-c663-4e75-a23b-5730431d5a7712016-05-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-26352083-263-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6131d788-1492-44e2-bd65-067ea949c5cfd32782b4-44bf-48b7-a540-b34715780e812021-01-08WarningsExact identifier
spl set id: d32782b4-44bf-48b7-a540-b34715780e81

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.