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

Gas Relief Ultra Strength by

Drug Labeling and Warnings

Gas Relief Ultra Strength by is a Otc medication manufactured, distributed, or labeled by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Simethicone 180 mg

Purpose

Antiflatulent

Usesfor relief of:

• bloating
• pressure
• fullness
• stuffed feeling commonly referred to as gas

Warnings

Stop use and ask a doctor if condition persists.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• swallow 1 or 2 softgels as needed after meals
• do not exceed 2 softgels per day unless directed by doctor

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
• protect from heat and moisture
• do not use if imprinted safety seal under cap is broken or missing

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"

INGREDIENTS AND APPEARANCE

GAS RELIEF ULTRA STRENGTH 
simethicone 180 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53345-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE 410 (UNII: TYU5GP6XGE) (DIMETHICONE 410 - UNII:TYU5GP6XGE)	DIMETHICONE 410	180 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE (oval)	Size	11mm
Flavor		Imprint Code	PC3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53345-003-03	1 in 1 BOX	04/15/2013
1		25000 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	04/15/2013

Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(53345-003) , ANALYSIS(53345-003)