Indications and uses
for prevention and treatment of nausea, vomiting, Uses or dizziness associated with motion sickness
BONINE
- Manufacturer
- WellSpring Pharmaceutical Corporation
- Effective date
- 2022-07-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:40:13
Label at a glance#
ProductBONINE Faster-Acting
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
■ dosage should be taken 30 minutes before you begin motion activity. ■ adults and children 12 years and over: take 1 to 2 tablets with Water every 4 to 6 hours, not to exceed 12 tablets (300 milligrams) in 24 hours, or as directed by a doctor. ■ Children 6 to under 12 years of age: take 1 tablet with Water every 4 to 6 hours, not to exceed 6 tablets (150 milligrams) in 24 hours, or as directed by a doctor.
Storage and handling
■ Each tablet contains: Calcium 60mg ■ Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F) ■ protect from moisture ■ see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.bonine.com
www.bonine.com
www.bonine.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Diphenhydramine HCl 25 mg
Purpose
Antiemetic
Uses
for prevention and treatment of nausea, vomiting, Uses or dizziness associated with motion sickness
Warnings
Do not use
■ for children under 6 years of age unless
■ Do not use with any other product containing diphenhydramine, including one used on skin
Ask a doctor before use if you have
■ difficulty in urination due to enlargement of the prostate gland
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic beverages
■ 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.
Directions
■ dosage should be taken 30 minutes before you begin motion activity.
■ adults and children 12 years and over: take 1 to 2 tablets with Water every 4 to 6 hours, not to exceed 12 tablets (300 milligrams) in 24 hours, or as directed by a doctor.
■ Children 6 to under 12 years of age: take 1 tablet with Water every 4 to 6 hours, not to exceed 6 tablets (150 milligrams) in 24 hours, or as directed by a doctor.
Other information
■ Each tablet contains: Calcium 60mg
■ Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F)
■ protect from moisture
■ see end flap for expiration date and lot number
Inactive ingredients
Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1, aluminum lake, magnesium stearate, microcrystalline cellulose, silicone dioxide, stearic acid
Questions?
1-844-241-5454 or www.bonine.com
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN. Keep Carton for important drug facts information.
Distributed by: WellSpring
Pharmaceutical Corporation
Sarasota, FL 34243
©2023 WellSpring
Pharmaceutical Corporation
Money Back Guarantee
PRINCIPAL DISPLAY PANEL 65197-616-16
NEW
9X the Adventure**
Diphenhydramine HCl - Antiemetic 25 mg
Prevents & Treats:
Vomiting • Nausea • Dizziness • Motion Sickness
*See back panel reference
* Than Meclizine HCL 25 mg per onset of action from The U.S. National Library of Medicine (NLM)
** Results may vary
FASTER-ACTING* RELIEF
TAKE WITH WATER
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65197-616-16 | 2025-03-25 | C162847 | 48780-1 | 2cef2736-7931-d83d-e063-dadaa90ab31f | BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC |
| 65197-616-16 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7931-d83d-e063-dadaa90ab31f | BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- BONINE Faster-Acting
- Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CROSCARMELLOSE SODIUM
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- FD&C BLUE NO. 1 ALUMINUM LAKE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE 101
- SILICON DIOXIDE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65197-616 | 65197-616-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 72ea173f-50b2-448c-8a70-842b19d899fd | 2c6f014d-6d46-4f8a-9196-904639dcb899 | 2022-07-06 | Warnings | 72ea173f-50b2-448c-8a70-842b19d899fd 2c6f014d-6d46-4f8a-9196-904639dcb899 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.