Label: MECLIZINE HYDROCHLORIDE tablet
- NDC Code(s): 24689-146-01
- Packager: APNAR PHARMA LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 9, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
• breathing problems, such as emphysema or chronic bronchitis
• difficulty urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• 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
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DOSAGE & ADMINISTRATION
Directions
- to prevent motion sickness, take the first dose one hour before starting activity
- not for frequent or prolonged use except on the advice of a doctor
- do not exceed recommended dose
Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- BOXED WARNING (What is this?)
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24689-146 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color yellow Score no score Shape ROUND Size 9mm Flavor Imprint Code AM4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24689-146-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M009 11/21/2022 Labeler - APNAR PHARMA LP (079568229) Establishment Name Address ID/FEI Business Operations APNAR PHARMA LLP 118530917 manufacture(24689-146) , analysis(24689-146) , pack(24689-146)
