Active Ingredient (In Each Chewable Tablet)
Meclizine HCl, USP 25 mg
Meclizine Hcl 25 Mg
FDA Label NDC 67296-1390
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug, Inc. for the product Meclizine Hcl 25 Mg (NDC 67296-1390). 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 (in each chewable tablet), purpose, uses, warnings, do not use, ask doctor, ask doctor/pharmacist, 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
Antiemetic
Uses
prevents and treats nausea, vomiting or dizziness due to motion sickness
Warnings
WARNINGS
Do Not Use
Do not use in children under 12 years of age unless directed by a doctor.
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
Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact the poison control center immediately.
Directions
Dosage should be taken one hour before travel starts.
Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.
Other Information
store at room temperature
Other Safety Information
Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
Do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.
Questions Or Comments?
If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.
When Using
When using this product
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution when driving a motor vehicle or operating machinery
Principal Display Panel
Meclizine 25mg (Doc20170525151422 001)
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