SIMETHICONE- simethicone capsule, liquid filled 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

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 CAPSULES 125 mg, liquid filled

Active ingredient (in each capsule)

Simethicone 125 mg

Purpose

Antiflatulent

Uses for relief of:

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules
NDC. No : 53345-009-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Shipping Label

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULE (OVAL) Size9mm
FlavorImprint Code PC2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53345-009-011 in 1 BOX04/15/2013
125000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/15/2013
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-009) , ANALYSIS(53345-009)

Revised: 11/2019
Document Id: 4dd36c12-b51b-4d08-8107-e16fbcb72e45
Set id: 0f9639fa-e1d0-460d-bc46-714a01cd9811
Version: 2
Effective Time: 20191106
 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.