Label: GAS RELIEF ULTRA STRENGTH- simethicone 180 mg capsule, liquid filled
- NDC Code(s): 53345-003-03
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 5, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Usesfor relief of:
- Warnings
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - Shipping Label
SIMETHICONE CAPSULES,180 mg
Quantity : 25000 Capsules
NDC. No : 53345-003-03IMPORTANT:
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"
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INGREDIENTS AND APPEARANCE
GAS RELIEF ULTRA STRENGTH
simethicone 180 mg capsule, liquid filledProduct 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)