FDA Label for Meclizine Hcl 12.5 Mg
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- 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 12.5 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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 Caplet)
Meclizine HCL 12.5 mg
Purpose
Antiemetic
Uses
• prevents and treats nausea, vomiting, or dizziness due to motion sickness• for other uses, consult your doctor
Warnings
Ask a docotor 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 product
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
• adults & children 12 years and over: 2-4 caplets once daily• children under 12 years: ask a doctor
Other Information
• each caplet contains: calcium 51 mg• store at room temperature 15°-30°C (59°-86°F)• This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
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
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320
Package Label.Principal Display Panel
NDC 71205-762-90
Meclizine HCL 12.5 mg
ANTIEMETIC
90 CAPLETS
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
* Please review the disclaimer below.