Storage and handling
Other information Each Caplet Contains: Calcium 25 mg store at room temperature in a dry place Keep lid tightly closed
Rugby
- Manufacturer
- NuCare Pharmaceuticals, Inc.
- Effective date
- 2017-05-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:16:19
Label at a glance#
ProductRugby Meclizine HCl, 12.5 mg Each Antiemetic
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure12 sections
Contacts and useful links#
Websitewww.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Meclizine HCl, USP 12.5 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 if 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: take 2-4 caplets 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
- Each Caplet Contains: Calcium 25 mg
- store at room temperature in a dry place
- Keep lid tightly closed
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 68071-3002-6 | 68071-3002-06-R68.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1017-01 | EA - Each | 0536-1017 | d858cbd4-182d-4c28-9d84-1eaca79de4b3 | 1 | 2014-11-05 |
| 0536-1017-10 | EA - Each | 0536-1017 | f3492dff-8835-4cfb-bc54-f996b4e41627 | 1 | 2014-11-05 |
Products#
Every source-derived product name is available through these pages.
- Rugby Meclizine HCl, 12.5 mg Each Antiemetic
- Meclizine HCl
- CROSCARMELLOSE SODIUM
- CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
- SODIUM SULFATE
- STEARIC ACID
- MECLIZINE HYDROCHLORIDE
- MECLIZINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-3002 | 68071-3002-4, 68071-3002-6, 68071-3002-2 |
| 0536-1017 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | O7TSZ97GEP | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM SULFATE | 0YPR65R21J | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| a4eb1429-b2d4-a779-e053-2a95a90ad0fc | 4fbbc3ec-8e90-512d-e054-00144ff8d46c | 2020-05-05 | Warnings | 4fbbc3ec-8e90-512d-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.