GAS RELIEF ULTRA STRENGTH- simethicone 180 mg 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 180 mg capsule, liquid filled

Active ingredient (in each capsule)

Simethicone 180 mg

Purpose

Antiflatulent

Usesfor 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

FD&C yellow#6, gelatin, glycerin, purified water, sorbitol special and white edible ink.

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

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES,180 mg

Quantity : 25000 Capsules
NDC. No : 53345-003-03

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

GAS RELIEF ULTRA STRENGTH 
simethicone 180 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE 410 (UNII: TYU5GP6XGE) (DIMETHICONE 410 - UNII:TYU5GP6XGE) DIMETHICONE 410180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULE (oval) Size11mm
FlavorImprint Code PC3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53345-003-031 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(53345-003) , ANALYSIS(53345-003)

Revised: 11/2019
Document Id: 4b6d6cc9-7122-4c32-9803-536063699a26
Set id: 2cfb8132-6de4-457d-880b-c870a38862ad
Version: 2
Effective Time: 20191105
 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.