Label: GAS RELIEF- simethicone tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-2860-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 37205-112
- 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 May 2, 2012
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- Active ingredients
- Purpose
- Use(s)
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- Inactive ingredients
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Principal display panel
NDC 54868-2860-0
Simethicone 80 mg
Gas Relief
•Pressure •Bloating •Discomfort
Fast Acting
Anti Gas
Mind Flavored
100 Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV1104E13712
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
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INGREDIENTS AND APPEARANCE
GAS RELIEF
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2860(NDC:37205-112) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor PEPPERMINT Imprint Code 44;137 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-2860-0 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 05/17/1995 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel