Label: GAS RELIEF- simethicone tablet, chewable
- NDC Code(s): 80136-859-68
- Packager: Northeast Pharma
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 30, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
- Warnings
-
Directions
- do not take more than directed
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime
- do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
Heartland®
Pharma Co.NDC 80136-859-68
Extra Strength
GAS RELIEF
Simethicone 125 mg Chewable Tablets
AntigasRelieves
Pressure
Bloating
DiscomfortCompare to the
active ingredient in
Gas-X® Extra Strength*Chew or crush tablets completely before swallowing.
100 Chewable Tablets
Actual
SizeTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by GSK Consumer
Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.
50844 ORG122060812
Distributed by:
NORTHEAST PHARMA
Williston, VT 05495
www.heartlandpharmaco.com
1-800-383-0648
Heartland Pharma 44-608
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INGREDIENTS AND APPEARANCE
GAS RELIEF
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80136-859 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 CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) SUCRALOSE (UNII: 96K6UQ3ZD4) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) DIMETHICONE 410 (UNII: TYU5GP6XGE) Product Characteristics Color pink Score no score Shape ROUND Size 14mm Flavor CHERRY Imprint Code 44;680 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80136-859-68 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M002 06/30/2023 Labeler - Northeast Pharma (081232935) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(80136-859) , pack(80136-859) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(80136-859)