NDC | 49483-333-01, 49483-333-10, 49483-333-16 |
Set ID | 7f3ce1e6-c0d6-4b56-8f7a-6368eb46901f |
Category | HUMAN OTC DRUG LABEL |
Packager | Time-Cap Labs, 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: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:49483-333-16 16 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/17/2018 2 NDC:49483-333-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018 3 NDC:49483-333-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/09/2010 Labeler - Time-Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc 037052099 manufacture(49483-333)