Active Indredient (In Each Caplet)
Meclizine HCL 12.5 mg
Meclizine Hcl 12.5 Mg Tablet
FDA Label NDC 69618-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Meclizine Hcl 12.5 Mg (NDC 69618-027). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active indredient (in each caplet), purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 tranquillizers 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 prodcut
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranqulizers 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 Laboratoires LLC, Valley Stream, NY 11580
Package Label.Principal Display Panel
NDC 69618-027-10
Meclizine HCL 12.5 mg
ANTIEMETIC
1000 CAPLETS
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
* Please review the disclaimer below.
