FDA Label for Travel Sickness Meclizine Hcl
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER SAFETY INFORMATION
- HOW SUPPLIED
Travel Sickness Meclizine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Unit Dose Services. 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.
Other
Drug Facts
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152
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
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