Active Ingredient
(in each tablet)
Meclizine HCl 25 mg
Meclizine Hcl
FDA Label NDC 33261-413
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 33261-413). 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 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
- 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
Other Information
- phenylketonurics: each tablet contains: phenylalanine 0.28mg
- store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor
Questions Or Comments
Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Rugby® Duluth, Georgia 30097
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Package Label.Principal Display Panel
Meclizine HCl
COMPARE TO ACTIVE INGREDIENT IN BONINE
Meclizine HCl 25 mg (ANTIEMETIC)
NDC 33261-0413-30
30 CHEWABLE TABLETS
Contains Aspartame
Rugby
Duluth, Georgia 30097
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Image Label (Meclizine HCl 25mg Chew Tab For Rugby 1)
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