Otc - Active Ingredient
Active ingredient (in each tablet)Meclizine HCl 25 mg
Motion-time Tablet, Chewable
FDA Label NDC 49483-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time-cap Labs, Inc for the product Motion-time (NDC 49483-333). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - do not use, otc - when using, 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
PurposeAntiemetic
Indications & Usage
Usesprevents and treats nausea, vomiting, or dizziness associated with motion sickness
Warnings
WarningsDo not give to children under 12 years of age unless directed by a doctor
Otc - Ask Doctor
Do not take unless directed by a doctor if you have
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
Otc - Do Not Use
Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor
Otc - When Using
When using this product
- do not exceed recommended dosage
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful 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.
Dosage & Administration
Directions
- dosage should be taken one hour before travel starts
- adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
Storage And Handling
Other information
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place
- use by expiration date on package
Inactive Ingredient
Inactive ingredients anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor
Package Label.Principal Display Panel
Meclizine HCL Chewable Tablets
Label Copy (333r)
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