Drug Facts
Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg
Meclizine Hydrochloride
FDA Label NDC 71610-526
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Meclizine Hydrochloride (NDC 71610-526). 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, otc - purpose, uses, do not use in, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiemetic
Uses
prevents and treats nausea, vomiting or dizziness due to motion sickness
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
Ask A Doctor Or Pharmacist Before Use If
you are taking sedatives or tranquilizers
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.
Overdosage
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 of age and over | chew 1 to 2 tablets once daily, or as directed by a doctor |
| children under
12 years of age | do not give this product to children under 12 years of age
unless directed by a doctor |
Other Information
Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium
store at room temperature in a dry place
keep lid tightly closed
Inactive Ingredient
Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid
Questions Or Comments?
1-800-645-2158
Other
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 25 mg |
| 30 | 71610-526-30 |
| 90 | 71610-526-60 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Aphena Pharma Solutions (TN)
Cookeville, TN 38506
20210318JH
Principal Display Panel - 25 Mg
NDC 71610-526 - Meclizine HCl 25 mg Tablets
Bottle Label 25 mg (71610 0526 30)
* Please review the disclaimer below.
