Label: SIMETHICONE capsule, liquid filled
- NDC Code(s): 53345-033-01
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., 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 8, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL - Shipping Label
SIMETHICONE CAPSULES, 125 mg
Quantity : 25000 Capsules
NDC. No : 53345-033-01IMPORTANT:
1.Inspect immediate upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.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:53345-033 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength 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) WATER (UNII: 059QF0KO0R) Product Characteristics Color green Score no score Shape CAPSULE (OVAL) Size 10mm Flavor Imprint Code 664 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-033-01 1 in 1 BOX 01/28/2015 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 01/28/2015 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 MANUFACTURE(53345-033) , ANALYSIS(53345-033)