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NDC 72189-0196-60 MECLIZINE HYDROCHLORIDE 25 mg/1 Details
MECLIZINE HYDROCHLORIDE 25 mg/1
MECLIZINE HYDROCHLORIDE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. The primary component is MECLIZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.
Related Packages: 72189-0196-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine
Product Information
| NDC | 72189-0196 |
|---|---|
| Product ID | 72189-196_e8917968-b5c1-fe3c-e053-2995a90a823b |
| Associated GPIs | 50200050000510 |
| GCN Sequence Number | 004736 |
| GCN Sequence Number Description | meclizine HCl TAB CHEW 25 MG ORAL |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 18312 |
| 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, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | MECLIZINE HYDROCHLORIDE |
| Labeler Name | DIRECT RX |
| Pharmaceutical Class | Antiemetic [EPC], Emesis Suppression [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part336 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 72189-0196-60 (72189019660)
| NDC Package Code | 72189-196-60 |
|---|---|
| Billing NDC | 72189019660 |
| Package | 60 TABLET, CHEWABLE in 1 BOTTLE (72189-196-60) |
| Marketing Start Date | 2021-04-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bfc7f3fc-9520-d7e4-e053-2a95a90a7d5c Details
SPL UNCLASSIFIED SECTION
Do not use in
children under 12 years of age unless directed by a 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
Ask a doctor or pharmacist before use if
you are taking sedatives or tranquilizers
When using this product
Do not exceed recommended dosage
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
SPL UNCLASSIFIED SECTION
Do not use in
children under 12 years of age unless directed by a 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
Ask a doctor or pharmacist before use if
you are taking sedatives or tranquilizers
When using this product
Do not exceed recommended dosage
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
INSTRUCTIONS FOR USE
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
INGREDIENTS AND APPEARANCE
| MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet, chewable |
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| Labeler - DIRECT RX (079254320) |
| Registrant - DIRECT RX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIRECT RX | 079254320 | repack(72189-196) | |