Otc - Active Ingredient
Active Ingredient (in each tablet)
12.5mg tablet: Meclizine HCL.... 12.5 mg
25mg tablet : Meclizine HCL .....25 mg
Meclizine Hydrochloride Tablet
FDA Label NDC 24689-138
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apnar Pharma Lp for the product Meclizine Hydrochloride (NDC 24689-138). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, inactive ingredient, storage and handling, warnings, otc - 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
Otc - Purpose
Purpose
Antiemetic
Indications & Usage
Uses
Prevents and treats nausea, vomiting or dizziness associated with motion sickness
Dosage & Administration
Directions
Meclizine HCL 12.5mg tablet :
Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor
Meclizine HCL 25mg tablet:
Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor
Inactive Ingredient
Inactive Ingredients
Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate
Storage And Handling
Other Information:
store at 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]
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 urination due to an enlarged prostate gland
- 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
Do not take this product if you are taking
Sedatives or tranquilizers, without first consulting your doctor.
When using this product,
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)
Otc - Questions
Questions or Comments?
Call 1-855-642-2594
Other
Rev.: 05/2022
Made in USA
Manufactured by:
APNAR PHARMA LLP
East Windsor, NJ 08520
Boxed Warning
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING
Package Label.Principal Display Panel
NDC : 24689-138-01
Meclizine Hydrochloride Tablets 12.5 mg
Antiemetic
100 Tablets
NDC : 24689-139-01
Meclizine Hydrochloride Tablets 25 mg
Antiemetic
100 Tablets
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