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DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Drug Facts
Distributed by: Plus Pharma, Commack, NY 11725
*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.
Meclizine Hcl 25 Mg
FDA Label NDC 71335-0143
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Meclizine Hcl 25 Mg (NDC 71335-0143). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Meclizine HCl, USP 25 mg
Otc - Purpose
Purpose
Antiemetic
Indications & Usage
Uses
prevents and treats nausea, vomiting or dizziness due to motion sickness
Warnings
Warnings
Otc - Do Not Use
Do not use in children under 12 years of age unless directed by a doctor.
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
- may cause drowsiness
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- use caution 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 the poison control center immediately.
Dosage & Administration
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
Storage And Handling
Other information
- phenylketonurics: contains phenylalanine 0.28 mg per tablet
- store at room temperature in a dry place
Inactive Ingredient
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.
Otc - Questions
Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.
How Supplied
Product: 71335-0143
NDC: 71335-0143-1 30 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-2 20 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-3 25 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-4 40 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-5 60 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-6 90 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-7 8 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-8 14 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-9 10 TABLET, CHEWABLE in a BOTTLE
NDC: 71335-0143-0 120 TABLET, CHEWABLE in a BOTTLE
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