Label: MECLIZINE HYDROCHLORIDE tablet
- NDC Code(s): 24689-146-01
- Packager: APNAR PHARMA LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 12, 2022
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- 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?)
- SPL UNCLASSIFIED SECTION
- 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 final 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)
