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| Product NDC Code | 65197-616 | ||||
|---|---|---|---|---|---|
| Drug Name | Bonine faster-acting |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 1049630 | ||||
| Application Number | part336 | ||||
| Labeler Name | WellSpring Pharmaceutical Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Diphenhydramine HCl 25 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1, aluminum lake, magnesium stearate, microcrystalline cellulose, silicone dioxide, stearic acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for prevention and treatment of nausea, vomiting, Uses or dizziness associated with motion sickness
Purpose
Information about the drug product’s indications for use.Purpose Antiemetic
Spl product data elements
Usually a list of ingredients in a drug product.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 WS1
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 Bonine Faster Acting 2.0 Bonine Faster Acting IFC
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-844-241-5454 or www.bonine.com
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API