NDC | 50436-0994-1 |
Set ID | ff14ae8b-bc67-4f79-958a-c2d968bfcc30 |
Category | HUMAN OTC DRUG LABEL |
Packager | Unit Dose Services |
Generic Name | |
Product Class | Antiemetic |
Product Number | |
Application Number | PART336 |
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
- Warnings
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- OTHER SAFETY INFORMATION
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- WHEN USING
- MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE
-
INGREDIENTS AND APPEARANCE
MECLIZINE HCL 25 MG
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-0994(NDC:51645-994) 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) SUCROSE (UNII: C151H8M554) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE (UNII: 0YPR65R21J) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color pink (Uncoated) Score 2 pieces Shape ROUND (Biconvex) Size 8mm Flavor RASPBERRY Imprint Code 21G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50436-0994-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 10/15/2015 Labeler - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-0994) , RELABEL(50436-0994)