OTC Medication Information: Simethicone

SIMETHICONE- dimethicone capsule, liquid filled
Preferred Pharmaceuticals, 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.

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

swallow one or two softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

edible ink, FD&C yellow #6, gelatin, glycerin, purified water

Questions or comments?

1-800-645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN ULTRA STRENGTH PHAZYME®*

Simethicone 180 mg

ANTIFLATULENT

Relieves Symptoms of Gas

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

*Rugby Laboratories is not affiliated with the owner of the trademark Ultra Strength Phazyme®.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Relabeled By: Preferred Pharmaceuticals Inc.

PRODUCT LABEL

Simethicone 180mg Softgels
(click image for full-size original)

Rugby Simethicone 180 mg

SIMETHICONE
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9285(NDC:0536-3604)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 180 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
GLYCERIN
WATER
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code S180
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9285-3 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:68788-9285-6 36 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 02/03/2015
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL (68788-9285)

Revised: 03/2019 Preferred Pharmaceuticals, 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.

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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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