OTC Medication Information: PHAZYME

PHAZYME- dimethicone capsule, gelatin coated
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

Active Ingredient (in each fast gel)

Simethicone 250 mg

Purpose

Anti-gas

Use

Relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists.

Keep out of reach of children .

Directions

  • Swallow one or two fast gels as symptoms occur.
  • Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician.

Other information

Store at room temperature 59º-86ºF (15º-30ºC).

Inactive In g redients

DC Red #33, FD&C Blue #1, gelatin, glycerin, purified water

Questions?

Call toll-free 1-855-727-4277

Principal Display Panel

PHAZYME®

ANTI-GAS SIMETHICONE 250 mg

MAXIMUM STRENGTH

12 fast gels

Principal Display Panel

PHAZYME® 
ANTI-GAS SIMETHICONE 250 mg

MAXIMUM STRENGTH 

12 fast gels
(click image for full-size original)
PHAZYME
simethicone capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0211
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 250 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33
FD&C BLUE NO. 1
GELATIN
GLYCERIN
WATER
Product Characteristics
Color purple Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code PZ;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0132-0211-12 1 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the BOX (0132-0211-12)
2 NDC:0132-0211-24 2 BLISTER PACK in 1 BOX contains a BLISTER PACK
2 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the BOX (0132-0211-24)
3 NDC:0132-0211-36 3 BLISTER PACK in 1 BOX contains a BLISTER PACK
3 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the BOX (0132-0211-36)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 04/01/2014
Labeler — C.B. Fleet Company, Inc. (003119054)

Revised: 05/2023 C.B. Fleet Company, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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