Drug Facts Active Ingredient (In Each Chewable Tablet)
Meclizine HCl, USP 25 mg
Meclizine Hcl Tablet, Chewable
FDA Label NDC 16571-824
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Meclizine Hcl (NDC 16571-824). 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 drug facts active ingredient (in each chewable tablet), purpose, uses, warnings, otc - ask doctor/pharmacist, when using this product, otc - pregnancy or breast feeding, keep out of reach of children., 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
Do not use in children under 12 years of age unless directed by a 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.
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.
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 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
- Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
- Store at room temperature in a dry place
- Keep lid tightly closed
Inactive Ingredients
aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate
Questions Or Comments?
Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET
Tamper Evident: Do Not Use If Foil Seal Under Cap, Printed With"Sealed For Your Protection" Is Broken Or Missing.Rising Pharma Holdings, Inc. Is Not Affiliated With The Owner Of The Registered Trademark Bonine®Manufactured By: Unique Pharmaceutical Laboratories(A Div. Of J.B. Chemicals & Pharmaceuticals Ltd.),Mumbai 400 030, Indiadistributed By:Rising Pharma Holdings, Inc.East Brunswick, Nj 08816Mfg. Lic. No.: G/1430Feb 2022
Principal Display Panel - 25 Mg Chewable Tablet Label
Meclizine Hydrochloride Chewable Tablets
25 mg
100 Tablets / 1000 tablets
Meclizine-100ct (Meclizine 100ct)
Meclizine-1000ct (Meclizine 1000ct)
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