Label: MECLIZINE HCL- meclizine hydrochloride chewable tablets tablet, chewable
-
Contains inactivated NDC Code(s)
NDC Code(s): 13811-648-01, 13811-648-10 - Packager: Trigen Laboratories, Inc.
- This is a repackaged label.
- Source NDC Code(s): 57631-009
- 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 September 15, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Uses:
- WARNING: Ask a doctor before use if you have
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR/PHARMACIST
- When using product
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Directions
- HOW SUPPLIED
- Other Information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label
-
INGREDIENTS AND APPEARANCE
MECLIZINE HCL
meclizine hydrochloride chewable tablets tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13811-648(NDC:57631-009) 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) LACTOSE (UNII: J2B2A4N98G) FD&C RED NO. 40 (UNII: WZB9127XOA) STARCH, CORN (UNII: O8232NY3SJ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) DEXTRATES (UNII: G263MI44RU) Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor RASPBERRY Imprint Code ET1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13811-648-10 100 in 1 BOTTLE 2 NDC:13811-648-01 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 09/23/2013 Labeler - Trigen Laboratories, Inc. (830479668) Registrant - Trigen Laboratories, Inc.. (830479668)
