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NDC 24689-0146-01 Meclizine Hydrochloride 25 mg/1 Details
Meclizine Hydrochloride 25 mg/1
Meclizine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by APNAR PHARMA LP. The primary component is MECLIZINE HYDROCHLORIDE.
Product Information
| NDC | 24689-0146 |
|---|---|
| Product ID | 24689-146_ed43bf21-f3db-245c-e053-2995a90a504c |
| Associated GPIs | |
| GCN Sequence Number | 004732 |
| GCN Sequence Number Description | meclizine HCl TABLET 25 MG ORAL |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 18302 |
| HICL Sequence Number | 001975 |
| HICL Sequence Number Description | MECLIZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Meclizine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Meclizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | MECLIZINE HYDROCHLORIDE |
| Labeler Name | APNAR PHARMA LP |
| Pharmaceutical Class | Antiemetic [EPC], Emesis Suppression [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | M009 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 24689-0146-01 (24689014601)
| NDC Package Code | 24689-146-01 |
|---|---|
| Billing NDC | 24689014601 |
| Package | 100 TABLET in 1 BOTTLE (24689-146-01) |
| Marketing Start Date | 2022-11-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ed43bf21-f3da-245c-e053-2995a90a504c Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet |
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| 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) | |