NDC | 68071-2178-2, 68071-2178-3, 68071-2178-4, 68071-2178-6 |
Set ID | 6f9010fe-e033-22cc-e053-2a91aa0a361e |
Category | HUMAN OTC DRUG LABEL |
Packager | NuCare Pharmceuticals,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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MECLIZINE HCL 25 MG
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-2178(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 (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (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:68071-2178-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 06/26/2018 2 NDC:68071-2178-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/26/2018 3 NDC:68071-2178-4 40 in 1 BOTTLE; Type 0: Not a Combination Product 06/26/2018 4 NDC:68071-2178-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 06/26/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 10/15/2015 Labeler - NuCare Pharmceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 repack(68071-2178)