FDA Label for Meclizine Hydrochloride
View Indications, Usage & Precautions
Meclizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Apnar Pharma Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient (in each tablet)
12.5mg tablet: Meclizine HCL.... 12.5 mg
25mg tablet : Meclizine HCL .....25 mg
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
* Please review the disclaimer below.