Label: NAUSX- meclizine hydrochloride tablet, chewable
- NDC Code(s): 72087-012-20
- Packager: Goldman Pharmaceutical Group Inc
- This is a repackaged label.
- Source NDC Code(s): 0536-1018
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 19, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not use with any other product containing meclizine
- ask a veterinarian before use if your dog has any chronic illnesses
- ask a veterinarian or pharmacist if your dog is on any other medication before use
- keep out of reach of children in case of overdose contact poison control center immediately
- stop use and contact veterinarian if symptoms persist for more than 72 hours
- do not use on dogs under 26 pounds
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
NAUSX
meclizine hydrochloride tablet, chewableProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:72087-012(NDC:0536-1018) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE (UNII: 0YPR65R21J) SUCROSE (UNII: C151H8M554) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color PINK (pink) Score 2 pieces Shape ROUND (biconvex tablet with bisect) Size 8mm Flavor Imprint Code 21G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72087-012-20 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 03/01/2019 Labeler - Goldman Pharmaceutical Group Inc (080389804) Registrant - Goldman Pharmaceutical Group, Inc. (080389804) Establishment Name Address ID/FEI Business Operations Goldman Pharmaceutical Group, Inc. 080389804 REPACK