Label: MECLIZINE- meclizine hcl 12.5 mg tablet
- NDC Code(s): 0536-1297-01, 0536-1297-10
- Packager: RUGBY LABORATORIES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2024
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 caplet)
- Purpose
- Uses
-
Warnings
Do not use in children under 12 years of age unless directed by a doctor.
Do not take this product, unless directed by a doctor, if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MECLIZINE
meclizine hcl 12.5 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1297 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape CAPSULE (CAPSULE SHAPED TABLET) Size 13mm Flavor Imprint Code PH049 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1297-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/21/2020 2 NDC:0536-1297-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M009 05/21/2020 Labeler - RUGBY LABORATORIES (079246066) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 analysis(0536-1297) , manufacture(0536-1297) , pack(0536-1297)