Drug Facts Active Ingredient (In Each Tablet)
Meclizine HCl, USP 12.5 mg
Meclizine Hcl Tablet
FDA Label NDC 57237-333
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 57237-333). 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 tablet), purpose, uses, warnings, when using this product, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, 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 associated with motion sickness.
Warnings
Do not use in children under 12 years of age unless directed by a doctor.
Do not take this product, unless directed by a doctor, if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Do not take this product if you are
taking sedatives or tranquilizers, without first consulting your doctor.
When Using This Product
- do not exceed recommended dosage
- 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 a Poison Control Center right away (1-800-222-1222).
Directions
dosage should be taken one hour before travel starts
| adults and children 12 years and over | take 2 or 4 tablets once daily or as directed by a doctor |
Other Information
- store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Inactive Ingredients
colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Questions Or Comments?
Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET
Other
Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J.B.Chemicals &
Pharmaceuticals Ltd.),
Mumbai 400 030, India
Mfg. Lic. No.: G/1430
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Issued: 02/2024
138528
Principal Display Panel - 12.5 Mg Tablets Container Label
NDC 57237-333-01
Meclizine Hydrochloride Tablets, USP
12.5 mg
100 Tablets
Meclizine-12.5mg-100ct (Meclizine 12.5mg 100ct) 
* Please review the disclaimer below.
