NDC | 68071-4595-2, 68071-4595-3, 68071-4595-4, 68071-4595-6 |
Set ID | 77f83f21-f880-6ac5-e053-2991aa0a8112 |
Category | HUMAN OTC DRUG LABEL |
Packager | NuCare Pharmaceuticals,Inc. |
Generic Name | |
Product Class | Antiemetic |
Product Number | |
Application Number | PART336 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- DO NOT USE
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MOTION-TIME CHEWABLE
meclizine hcl tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4595(NDC:49483-333) 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 in 25 Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSPOVIDONE (UNII: 68401960MK) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) RASPBERRY (UNII: 4N14V5R27W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) VANILLA (UNII: Q74T35078H) Product Characteristics Color pink Score 2 pieces Shape ROUND Size 9mm Flavor RASPBERRY Imprint Code TCL333 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-4595-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/11/2018 2 NDC:68071-4595-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 10/11/2018 3 NDC:68071-4595-4 40 in 1 BOTTLE; Type 0: Not a Combination Product 10/11/2018 4 NDC:68071-4595-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/09/2010 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 repack(68071-4595)