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| Product NDC Code | 65197-520 | ||||
|---|---|---|---|---|---|
| Drug Name | Bonine max |
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| Type | Brand | ||||
| Pharm Class | Antiemetic [EPC], Emesis Suppression [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 2632643 | ||||
| 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) Meclizine HCl 50 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 • do not take more than directed • dosage should be taken one hour before travel starts • Chew or crush tablet completely before swallowing; do not swallow tablet whole • adults and children 12 years of age and over: take 1 chewable tablet once daily or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, sodium saccharin, silicon dioxide
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 prevents and treats nausea, vomiting 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 MAX meclizine hydrochloride MECLIZINE HYDROCHLORIDE MECLIZINE ANHYDROUS LACTOSE STARCH, CORN PEPPERMINT FD&C RED NO. 40 SACCHARIN SODIUM MAGNESIUM STEARATE SILICON DIOXIDE BMX
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 NEW! 9x the Adventure** Meclizine HCL - Antiemetic 50 mg Prevents and treats: Dizziness - Nausea - Vomiting - Motion sickness 50 mg MECLIZINE HCL Nothing Stronger without a Prescription Bonine MAX Bonine MAX 16 CT Carton
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.NDC 65197-520-16 BONINE MAX STRENGTH Prevents and treats: Dizziness - Nausea - Vomiting - Motion sickness ** Results may vary ATTENTION: DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING. Keep carton for important drug facts information. MONEY BACK GUARANTEED Dist. by: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 USA © 2023 WellSpring Pharmaceutical Corporation
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 a breathing problem such as emphysema or chronic bronchitis
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 12 years of age unless directed by a doctor.
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? call toll-free 1 (844) 241-5454 or visit us on the web at 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 alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery drowsiness may occur avoid alcoholic drinks
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 store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F) protect from heat and humidity 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 12 years of age unless directed by a doctor. Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery drowsiness may occur avoid alcoholic drinks 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