Label: MECLIZINE HCL- meclizine hydrochloride tablet
- NDC Code(s): 16571-751-01, 16571-752-01
- Packager: Rising Pharma Holdings, Inc.
- 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 October 7, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts Active ingredient (in each tablet)
- PURPOSE
- Uses
- Directions
- Inactive Ingredients
- Other Information
- Questions or Comments?
- Warnings
- DO NOT USE
- When using this product
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MECLIZINE HCL
meclizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16571-751 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white (White to off white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code A;C4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16571-751-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/17/2021 MECLIZINE HCL
meclizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16571-752 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white (White to off white) Score no score Shape ROUND Size 9mm Flavor Imprint Code AM7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16571-752-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/17/2021 Labeler - Rising Pharma Holdings, Inc. (835513529) Registrant - Aurex Laboratories Limited Liability Company (067585317) Establishment Name Address ID/FEI Business Operations Aurex Laboratories Limited Liability Company 067585317 manufacture(16571-751, 16571-752) , pack(16571-751, 16571-752) , analysis(16571-751, 16571-752) , label(16571-751, 16571-752)