Label: MECLIZINE- meclizine hcl 12.5mg tablet
- NDC Code(s): 73057-386-08, 73057-386-11
- Packager: Ulai Health LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 20, 2025
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.
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MECLIZINE
meclizine hcl 12.5mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73057-386 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:73057-386-11 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2019 2 NDC:73057-386-08 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M009 07/08/2019 Labeler - Ulai Health LLC (081181535)

