MECLIZINE HYDROCHLORIDE
- Manufacturer
- DIRECT RX
- Effective date
- 2023-09-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:25:34
Label at a glance#
ProductMECLIZINE HYDROCHLORIDE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure12 sections
Contacts and useful links#
Websitewww.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
DRUG INTERACTIONS SECTION
Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg
OTC - PURPOSE SECTION
Purpose
Antiemetic
OTC - WHEN USING SECTION
prevents and treats nausea, vomiting or dizziness due to motion sickness
OTC - KEEP OUT OF REACH OF CHILDREN 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).
WARNINGS 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 SECTION
Dosage should be taken one hour before travel starts
adults and children 12
years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor
children under
12 years of age do not give this product to children under 12 years of age
unless directed by a doctor
OTC - QUESTIONS SECTION
Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium
store at room temperature in a dry place
keep lid tightly closed
INACTIVE INGREDIENT SECTION
Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid
OTC - QUESTIONS SECTION
1-800-645-2158
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-196-30 | EA - Each | 72189-196 | c8280364-91b8-4e0a-b844-a7946dfeb887 | 1 | 2021-05-05 |
| 72189-196-60 | EA - Each | 72189-196 | 0b60251c-2a5e-4de1-a48e-562d25c0ffe1 | 1 | 2022-09-12 |
| 0536-1299-10 | EA - Each | 0536-1299 | 4be88e27-d239-44c2-93e3-eb1867badd82 | 1 | 2021-02-05 |
Products#
Every source-derived product name is available through these pages.
- MECLIZINE HYDROCHLORIDE
- MECLIZINE
- STEARIC ACID
- SILICON DIOXIDE
- CROSPOVIDONE
- MAGNESIUM STEARATE
- RASPBERRY
- LACTOSE MONOHYDRATE
- CROSCARMELLOSE SODIUM
- FD&C RED NO. 40
- SACCHARIN SODIUM
- VANILLA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-196 | 72189-196-30, 72189-196-60 |
| 0536-1299 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MECLIZINE HYDROCHLORIDE | HDP7W44CIO | ACTIB |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| RASPBERRY | 4N14V5R27W | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| VANILLA | Q74T35078H | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Rugby Laboratories | b57f14a7-3852-03db-e053-2a95a90a80d6 | 2026-07-16 | Warnings | 0536-1299 |
| 07d9743b-924d-0c19-e063-6294a90acda8 | bfc7f3fc-9520-d7e4-e053-2a95a90a7d5c | 2023-10-16 | Warnings | bfc7f3fc-9520-d7e4-e053-2a95a90a7d5c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.