NDC | 59779-534-01 |
Set ID | 2a723bce-a581-4558-b028-22f1f9125dd5 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy, Inc. |
Generic Name | |
Product Class | Antiemetic |
Product Number | |
Application Number | PART336 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
Uses
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■ For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness. - WARNINGS
Warnings
Ask a doctor before use if you have
■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate glandWhen using this product
■ you may get drowsy ■ avoid alcoholic beverages
■ be careful when driving a motor vehicle or operating machinery
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effectKeep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
Directions
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To prevent motion sickness take it at least one hour before traveling
Adults and children 12 years of age and over: take 1 to 2 (25 to 50 mg) tablets once daily, or as directed by a physician. - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
Inactive ingredients
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acesulfame potassium, erythritol, hydroxypropyl cellulose, colloidal silicon dioxide, mannitol, menthol, sodium stearyl fumarate, yellow ferric oxide. - INGREDIENTS AND APPEARANCE
CVS MOTION SICKNESS FAST MELTING
meclizine hydrochloride tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-534 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength ERYTHRITOL (UNII: RA96B954X6) MANNITOL (UNII: 3OWL53L36A) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LEVOMENTHOL (UNII: BZ1R15MTK7) Product Characteristics Color yellow Score no score Shape ROUND Size 13mm Flavor Imprint Code SJ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-534-01 1 in 1 CARTON 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/27/2015 Labeler - CVS Pharmacy, Inc. (062312574)