Otc - Active Ingredient
Active ingredient (in each tablet)
Meclizine Hydrochloride 25 mg
Medique Medi-meclizine Tablet
FDA Label NDC 85766-175
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sportpharm Llc for the product Medique Medi-meclizine (NDC 85766-175). 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, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, 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
for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.
Warnings
Warnings
Otc - Do Not Use
Do not usefor children under 12 years of age unless directed by a doctor.
Otc - Ask Doctor
Ask a doctor before use if you have
■ difficulty in urination due to enlargement of the prostate gland
■ glaucoma
■ a breathing problems such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.
Otc - When Using
When using this product
■ drowsiness may occur
■ avoid alcoholic beverages
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ 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
(1-800-222-1222) right away.
Dosage & Administration
Directions
- Do not take more than directed
- take the first dose ½ hour to 1 hour before starting activity
Adults and children: (12 years and older)1 to 2 tablets once daily, or as directed by a doctor.
Children under 12 years:Do not give to children under 12 years of age.
Other Safety Information
Other information
■ tamper-evident sealed packets
■ do not use any opened or torn packets
■ store at 77°F (25°C); excursions permitted between 59- 86° F (15-30°C)
■ protect from heat and humidity
■ use by expiration date on packet
Inactive Ingredient
Inactive ingredients
corn starch, D&C yellow # 10 aluminum lake, lactose monohydrate, magnesium stearate, silicon dioxide
Otc - Questions
Questions or comments?Call 1-800-634-7680
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