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
- 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 January 31, 2022
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- 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 final part336 07/08/2019 Labeler - Ulai Health LLC (081181535)