NDC | 67296-1390-3 |
Set ID | 505f6036-d216-4455-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | RedPharm Drug, Inc. |
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
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MECLIZINE HCL 25 MG
meclizine hcl 25 mg tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1390(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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) ASPARTAME (UNII: Z0H242BBR1) SUCROSE (UNII: C151H8M554) DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE (UNII: 0YPR65R21J) Product Characteristics Color pink (uncoated) Score 2 pieces Shape ROUND (bioconvex) Size 8mm Flavor RASPBERRY Imprint Code 21G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67296-1390-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 10/15/2015 Labeler - RedPharm Drug, Inc. (828374897) Establishment Name Address ID/FEI Business Operations RedPharm Drug, Inc. 828374897 repack(67296-1390) , relabel(67296-1390)