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| Product NDC Code | 65197-275 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Bonine |
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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 | 995632, 995634 |
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| Application Number | M009 | ||||||||||
| 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 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 (65197-275) dosage should be taken one hour before travel starts adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
Directions (65197-296) dosage should be taken one hour before travel starts chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (65197-275) croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor.
Inactive Ingredients (65197-296) corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, 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 meclizine hydrochloride MECLIZINE HYDROCHLORIDE MECLIZINE CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C RED NO. 40 MAGNESIUM STEARATE SILICON DIOXIDE SACCHARIN SODIUM STEARIC ACID LACTOSE MONOHYDRATE RASPBERRY VANILLA light pink Bonine;201 BONINE meclizine hydrochloride MECLIZINE HYDROCHLORIDE MECLIZINE STARCH, CORN FD&C RED NO. 40 RASPBERRY LACTOSE MONOHYDRATE MAGNESIUM STEARATE SACCHARIN SODIUM SILICON DIOXIDE Bonine;201
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-275 UP TO 24 HOUR PROTECTION BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC Nausea - Dizziness - Vomiting *Less drowsy than Dramamine Bonine 12 ct Bonine 12 ct
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-296 NEW LOOK! Same great formula 9X the Adventure** **Results may vary. Meclizine HCL • Antiemetic 25mg *Less drowsy than Dramamine ® BONINE ® MECLIZINE HCL Prevents & Treats: Motion Sickness / Nausea & Vomiting / Dizziness / Cyber Sickness Up to 24 Hours Relief Bonine 8ct Blue new Design Bonine 8ct Blue new Design
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.Dist. by: WellSpring Pharmaceutical Corporation Sarasota, FL 34243 ©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.Do not take this product, unless directed by a doctor, if you have glaucoma trouble urinating due to an enlarged prostate gland 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 in children under 12 years of age unless directed by a doctor.
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your 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? 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 do not exceed recommended dosage you may get drowsy alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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 TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.TAMPER EVIDENT 65197-275 TAMPER EVIDENT: DO NOT USE IF TAMPER EVIDENCE TAPE OVER CAP IS BROKEN OR MISSING.
TAMPER EVIDENT 65197-296 ATTENTION: DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING. Keep Carton for important drug facts information.
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 in children under 12 years of age unless directed by a doctor. Do not take this product, unless directed by a doctor, if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product do not exceed recommended dosage you may get drowsy alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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