NDC | 51645-994-01, 51645-994-10 |
Set ID | 18a59c8a-6d8a-2ad0-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Gemini Pharmaceuticals, Inc. dba Plus Pharma |
Generic Name | |
Product Class | Antiemetic |
Product Number | |
Application Number | PART336 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL
NDC 51645-994-01
Plus Pharma™
MECLIZINE HCl 25 mg
ANTIEMETIC
Treats and Prevents Motion Sickness
*Compare to the Active Ingredient in Bonine®
Prevents nausea, dizziness and vomiting
Raspberry
Natural & Artificial Flavor
Contains no ingredient from gluten-containing grain (wheat, barley, or rye).
100 CHEWABLE TABLETS • 25 mg each
-
PRINCIPAL DISPLAY PANEL
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
Plus Pharma™
NDC 51645-994-10
MECLIZINE HCl 25 mg
ANTIEMETIC
Treats and Prevents Motion Sickness
Prevents nausea, dizziness and vomiting
*Compare to the Active Ingredient in Bonine®
Raspberry
Natural & Artificial Flavor
Contains no ingredient from a gluten-containing grain (wheat, barley, or rye).
1000 CHEWABLE TABLETS • 25 mg each
-
INGREDIENTS AND APPEARANCE
MECLIZINE HCL 25 MG
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:51645-994-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/15/2015 2 NDC:51645-994-10 1000 in 1 BOTTLE, PLASTIC; 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 - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270) Establishment Name Address ID/FEI Business Operations Gemini Pharmaceuticals, Inc. 055942270 manufacture(51645-994)