![MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS) TABLET, CHEWABLE [TRIGEN LABORATORIES, INC.]](https://medic.hrt.org//dailymed/images/ccab7b75-29c0-4024-a4a0-e506732e56ab/image-100cts.jpg)
| NDC | 13811-648-01, 13811-648-10 |
| Set ID | ccab7b75-29c0-4024-a4a0-e506732e56ab |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Trigen Laboratories, Inc. |
| Generic Name | |
| Product Class | Antiemetic |
| Product Number | |
| Application Number | PART336 |
- Active Ingredients (in each tablet)
- Purpose
- Uses:
prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor.
Close - WARNING: Ask a doctor before use if you have
• Glaucoma • A breathing problem such as emphysema or chronic bronchitis • Trouble urinating due to an enlarged prostate gland.
Close - KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR/PHARMACIST
- When using product
• You may get drowsy • Avoid alcoholic drinks • Alcohol, sedatives and tranquilizers may increase drowsiness • Be careful when driving a motor vehicle or operating machinery
Close - PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Directions
• Take dose one hour before travel starts • Tablets can be chewed or swallowed whole with water • Adults & children 12 years and over: 1-2 tablets once daily • Children under 12 years: ask a doctor
Close - Other Information
- Inactive ingredients
Microcrystalline cellulose, magnesium stearate, lactose, Raspberry flavor, FD&C Red #40 lake, starch, sodium saccharin, and dextrates hydrated.
Close - SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
TRIGEN
LABORATORIESManufactured for:
Close
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 08/13 - 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) CloseRegistrant - Trigen Laboratories, Inc.. (830479668)
