PHAZYME

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:41:37

Label at a glance#

ProductPHAZYME
Active ingredientCALCIUM CARBONATE, DIMETHICONE
Label structure9 sections

Dosage and administration

Adults and children 12 years and older: Chew and swallow 1 to 2 chews as symptoms occur or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

PHAZYME- simethicone and calcium carbonate tablet, chewable 
C.B. Fleet Company, Inc.

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.

----------

Drug Facts

Purpose

OTC - PURPOSE SECTION

Calcium carbonate 750mg………………………………Antacid

Simethicone 250mg……………………………………Anti-gas

Use

INDICATIONS & USAGE SECTION

for the relief of:

  • Pressure and bloating commonly referred to as gas
  • Acid indigestion
  • Heartburn
  • Sour stomach
  • Upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

  • Do not take more than 2 chews in a 24-hour period
  • Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor

Ask a doctor or pharmacist before using if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • Now taking a prescription drug. Antacids may interact with certain prescription drugs

If pregnant or breastfeeding, ask a doctor before use

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older:

Chew and swallow 1 to 2 chews as symptoms occur or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

Each chew contains: calcium 300mg

  • Store at room temperature between 59°-77°F
  • Don’t use if allergic to this product or its ingredients

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, beeswax, carnuba wax, citric acid, cornstarch, corn syrup, FD&C red #40 aluminum lake, flavor, modified starch, phosphoric acid, polyvinylpyrolidone, pregelatinized modified corn starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil, water

Questions?

OTC - QUESTIONS SECTION

1-855-727-4277 or phazyme.com

Dist. by Medtech Products Inc., Tarrytown, NY 10591

A Prestige Brands Company

©2020 Trade dress is owned by C.B. Fleet Company, Inc.. All rights reserved.

Made & Packaged in the USA

PZUS006202

Tamper Evident:

Do not use if foil imprinted “SEALED FOR YOUR PROTECTION” under cap is torn or missing

*The strongest OTC gas relief per 2 chewables

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHAZYME
GAS & ACID

Cherry Flavor

24
 chewables

PRINCIPAL DISPLAY PANEL PHAZYME GAS & ACID Cherry Flavor 24 chewablesPRINCIPAL DISPLAY PANEL PHAZYME GAS & ACID Cherry Flavor 24 chewables

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0507PHAZYME (SIMETHICONE AND CALCIUM CARBONATE) TABLET, CHEWABLE [C.B. FLEET COMPANY, INC.]6Legacy NDC20250202_848d7c23-a12b-49c4-8fda-da15efca33ad.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-05070132-0507-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
c1844ca5-1c53-44d5-a5bc-b9fbd3c5b9d9848d7c23-a12b-49c4-8fda-da15efca33ad2025-02-04WarningsExact identifier
spl id: c1844ca5-1c53-44d5-a5bc-b9fbd3c5b9d9
spl set id: 848d7c23-a12b-49c4-8fda-da15efca33ad

Reported adverse events (FAERS/openFDA)#

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