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NDC 00132-0507-24 PHAZYME 750; 250 mg/241; mg/241 Details

PHAZYME 750; 250 mg/241; mg/241

PHAZYME is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is CALCIUM CARBONATE; DIMETHICONE.

MedlinePlus Drug Summary

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00132-0507-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00132-0507-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00132-0507
Product ID	0132-0507_428c1326-85da-4bc5-a2ae-1f7e10e31ef0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PHAZYME
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone and Calcium Carbonate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	750; 250
Active Ingredient Units	mg/241; mg/241
Substance Name	CALCIUM CARBONATE; DIMETHICONE
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0507-24 (00132050724)

Pricing Information	N/A
NDC Package Code	0132-0507-24
Billing NDC	00132050724
Package	24 TABLET, CHEWABLE in 1 JAR (0132-0507-24)
Marketing Start Date	2016-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 848d7c23-a12b-49c4-8fda-da15efca33ad Details

Active Ingredients (in each chew)

Calcium carbonate 750mg............... Antacid

Simethicone 250mg.................. Anti-gas

Uses for the relief of:

pressure and bloating commonly referred to as gas
acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

When using this product

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

If pregnant or breast-feeding

Ask a doctor before use.

Ask a doctor or pharmacist before use if you are

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

Keep out of reach of children

Keep out of reach of children.

Directions

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

Each chew contains: calcium 300mg
Store between 59-77F.
Don't use if allergic to this product or its ingredients.

Inactive Ingredients

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?

1-855-727-4277 or www.phazyme.com

Principle Display Panel

INGREDIENTS AND APPEARANCE

PHAZYME

simethicone and calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0507
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	750 mg in 24
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg in 24

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
STARCH, CORN (UNII: O8232NY3SJ)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
PHOSPHORIC ACID (UNII: E4GA8884NN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	12mm
Flavor	CHERRY	Imprint Code	PA
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0132-0507-24	24 in 1 JAR; Type 0: Not a Combination Product	03/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	03/01/2016

Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 10/2017

Document Id: 428c1326-85da-4bc5-a2ae-1f7e10e31ef0

Set id: 848d7c23-a12b-49c4-8fda-da15efca33ad

Version: 3

Effective Time: 20171019