Active Ingredient
(in each caplet)
Meclizine HCl 12.5 mg USP
Meclizine Hcl
FDA Label NDC 33261-748
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Meclizine Hcl (NDC 33261-748). 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 ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments, 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
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 & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating a machinery
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.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
Directions
- adults and 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)
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions Or Comments
Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED
Rugby® Duluth, Georgia 30097
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Package Label.Principal Display Panel
NDC 33261-0748-30
Meclizine HCl 12.5 mg Caplets USP
Antiemetic
30 caplets
Image Label (Meclizine HCl 12 5mg Tab For Rugby 1) 
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