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Drug Facts
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152
Rugby Travel Sickness
FDA Label NDC 67296-1128
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug, Inc. for the product Rugby Travel Sickness (NDC 67296-1128). 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, active ingredient, purpose, indications & usage, warnings, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Active ingredient (in each chewable tablet)
Meclizine HCl USP 25 mg
Purpose
Purpose
Antiemetic
Indications & Usage
Uses prevents and treats nausea, vomiting or dizziness due to motion sickness
Warnings
Warnings
Do not use in children under 12 years of age unless directed by a 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
Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.
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
If pregnant or breast-feeding, ask a health professional before use.
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
nactive 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.
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
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact the poison control center immediately.
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Meclizine Chew 25mg (Doc20170504112038 001)
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