FDA Label for Meclizine Hcl 25 Mg
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Meclizine Hcl 25 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Remedyrepack Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Meclizine HCL 25 mg
Purpose
Antiemetic
Uses
- prevents and treats nausea, vomiting or dizziness due to motion sickness
- for others uses, consult your doctor
Warnings
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
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this prodcut
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 unser 12 years: ask a doctor
Other Information
- Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
- store at room temperature 15°-30°C (59°-86°F)
- This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Inactive Ingredients
aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor
Questions Or Comments?
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Package Label.Principal Display Panel
DRUG: Meclizine HCL 25 mg
GENERIC: Meclizine HCL
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-3201-0
COLOR: pink
FLAVOR: RASPBERRY
SHAPE: ROUND
SCORE: Two even pieces
SIZE: 8 mm
IMPRINT: AP;115
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- MECLIZINE HYDROCHLORIDE 25mg in 1
- DEXTROSE
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- RASPBERRY
- ASPARTAME
- SUCROSE
- CROSCARMELLOSE SODIUM
INACTIVE INGREDIENT(S):
* Please review the disclaimer below.