Label: SIMETHICONE capsule, liquid filled
- NDC Code(s): 53345-032-02
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- Category: HUMAN OTC DRUG LABEL
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 8, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - Shipping Label
Simethicone Capsules 250 mg
NDC 53345-032-02
Quantity: 12 Capsules per blister
124 Blisters per box
IMPORTANT:
Inspect immediately upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING -
INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-032 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 250 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color purple (clear) Score no score Shape capsule (oval) Size 13mm Flavor Imprint Code PC31 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-032-02 124 in 1 BOX 06/30/2016 1 12 in 1 BLISTER PACK; 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 06/30/2016 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd 421293287 manufacture(53345-032) , analysis(53345-032)