SIMETHICONE- simethicone capsule, liquid filled
AiPing Pharmaceutical, 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.

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Simethicone Softgels, USP 125 mg

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

store at controlled room temperature 20 - 25 ºC (68-77 ºF)
protect from light, heat and moisture

TAMPER EVIDENT FEATURE:

Simethicone Softgels, USP 125 mg are sealed in blister packets. Use only if the individual seal in unbroken

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, peppermint oil, purified water, sorbitol, titanium dioxide and white edible ink

Questions or comments?

Call 1-844-374-0016

Principal Display Panel

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R. China

simethicone 125mg

SIMETHICONE
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11788-031
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE (oval)	Size	10mm
Flavor		Imprint Code	AP31
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11788-031-12	1 in 1 CARTON	09/01/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	09/01/2017	12/31/2019

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Name	Address	ID/FEI	Business Operations
Establishment
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-031) , analysis(11788-031)

Revised: 5/2021

Document Id: c329a467-6abd-81cc-e053-2a95a90aaacd

Set id: 597d597b-ca56-7c1c-e053-2991aa0a8edb

Version: 3

Effective Time: 20210525

AiPing Pharmaceutical, Inc.