Label: MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable
- NDC Code(s): 51645-994-01, 51645-994-10
- Packager: Gemini Pharmaceuticals, Inc. dba Plus Pharma
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)