Storage and handling
Other information Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet Store at room temperature in a dry place Keep lid tightly closed
TRAVEL SICKNESS CHEWABLE TABLETS
- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Effective date
- 2019-03-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:29:03
Label at a glance#
ProductRugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic)
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure13 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each chewable tablet)
Meclizine HCl USP 25 mg
OTC - PURPOSE SECTION
Purpose
Antiemetic
INDICATIONS & USAGE SECTION
Uses prevents and treats nausea, vomiting or dizziness due to motion sickness
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use in children under 12 years of age unless directed by a doctor
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.
OTC - WHEN USING SECTION
When using this product
- may cause drowsiness
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- use caution when driving a motor vehicle or operating machinery
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact the poison control center immediately.
DOSAGE & ADMINISTRATION SECTION
Directions
- Dosage should be taken one hour before travel starts
- Adults and children 12 years of age and older: Chew 1-2 tablets once daily, or as directed by a doctor
- Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor
STORAGE AND HANDLING SECTION
Other information
- Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
- Store at room temperature in a dry place
- Keep lid tightly closed
INACTIVE INGREDIENT SECTION
Inactive ingredients
aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.
OTC - QUESTIONS SECTION
Questions or comments?
call 1-800-645-2158
OTHER SAFETY INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
SPL UNCLASSIFIED SECTION
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 25 mg |
| 30 | 71610-245-30 |
| 90 | 71610-245-60 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20190314JH
PRINCIPAL DISPLAY PANEL - 25 mg
NDC 71610-245 - Meclizine HCl (Travel Sickness) 25 mg Chewable Tablets
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-245-30 | EA - Each | 71610-245 | 30b13301-712d-414a-aa7c-388629963930 | 1 | 2020-07-13 |
| 71610-245-60 | EA - Each | 71610-245 | 949c69a8-84f3-40f0-898d-614a3f599df9 | 1 | 2020-07-13 |
| 0536-1018-01 | EA - Each | 0536-1018 | 38974734-0ca3-472f-a497-87a548eaec94 | 1 | 2014-09-03 |
| 0536-1018-10 | EA - Each | 0536-1018 | f375fa7f-4c57-4dd0-8d08-870621e0e1e7 | 1 | 2014-10-03 |
Products#
Every source-derived product name is available through these pages.
- Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic)
- Meclizine HCl
- ASPARTAME
- CROSCARMELLOSE SODIUM
- DEXTROSE
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- MALTODEXTRIN
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
- SODIUM SULFATE
- SUCROSE
- TRICALCIUM PHOSPHATE
- MECLIZINE HYDROCHLORIDE
- MECLIZINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71610-245 | 71610-245-30, 71610-245-60 |
| 0536-1018 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPARTAME | Z0H242BBR1 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM SULFATE | 0YPR65R21J | IACT |
| SUCROSE | C151H8M554 | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
| MECLIZINE HYDROCHLORIDE | HDP7W44CIO | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 36392e4c-439d-c854-e063-6294a90a5dcc | 099d75cc-a2c7-4140-9884-b45010aaf2b5 | 2025-05-28 | Warnings | 099d75cc-a2c7-4140-9884-b45010aaf2b5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.