PHAZYME- simethicone and calcium carbonate tablet, chewable

PHAZYME by

Drug Labeling and Warnings

PHAZYME by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

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