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Drug Facts
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152
Travel Sickness Meclizine Hcl
FDA Label NDC 50436-3989
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unit Dose Services for the product Travel Sickness Meclizine Hcl (NDC 50436-3989). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Meclizine HCl USP 25 mg
Otc - Purpose
Purpose
Antiemetic
Indications & Usage
Uses prevents and treats nausea, vomiting or dizziness due to motion sickness
Warnings
Warnings
Otc - Do Not Use
Do not use in children under 12 years of age unless directed by a doctor
Otc - Ask 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.
Otc - When Using
When using this product
- 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. In case of overdose, get medical help or contact the poison control center immediately.
Dosage & Administration
Directions
- Dosage should be taken one hour before travel starts
- Adults and children 12 years of age and older: Chew 1-2 tablets once daily, or as directed by a doctor
- Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor
Storage And Handling
Other information
- Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
- Store at room temperature in a dry place
- Keep lid tightly closed
Inactive Ingredient
Inactive ingredients
aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.
Otc - Questions
Questions or comments?
call 1-800-645-2158
Other Safety Information
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
How Supplied
Product: 50436-3989
NDC: 50436-3989-1 30 TABLET, CHEWABLE in a BOTTLE
* Please review the disclaimer below.
