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| Product NDC Code | 63941-710 | ||||
|---|---|---|---|---|---|
| Drug Name | Best choice childrens allergy relief bubblegum flavor |
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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 | LIQUID | ||||
| RxCUI drug identifier | 1049906 | ||||
| Application Number | part341 | ||||
| Labeler Name | BEST CHOICE (VALU MERCHANDISERS COMPANY) | ||||
| 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 5 mL) Diphenhydramine HCl USP 12.5 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 ▪ find right dose on chart below ▪ take every 4 to 6 hours, or as directed by a doctor ▪ do not take more than 6 doses in 24 hours ▪ mL = milliliter Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
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 ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the throat or nose
Purpose
Information about the drug product’s indications for use.Purpose Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Best Choice Childrens Allergy Relief Bubblegum flavor Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GLYCERIN POTASSIUM CITRATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE
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 Best Choice ® NDC 63941-710-04 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S BENADRYL ® DYE-FREE * DYE-FREE Children’s Allergy Liquid Diphenhydramine HCl/Antihistamine Oral Solution For Relief of: • Runny Nose • Itchy Throat or Nose • Sneezing • Itching, Watery Eyes SUGAR FREE BUBBLEGUM FLAVOR Naturally and artificially flavored 4 FL OZ (118 mL) IMPORTANT: Keep this carton for future reference on full labeling. www.StopMedicineAbuse.org *This product is not manufactured or distributed by Johnson & Johnson owner of the registered trademark Children’s Benadryl ® Dye-Free TEMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING Children's allergy liquid Bubblegum Flavor
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 the child has ▪ a breathing problem such as chronic bronchitis ▪ glaucoma
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.
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 ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even 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 at (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-467-2748
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 ▪ sedatives and tranquilizers may increase drowsiness ▪ excitability may occur, especially in children
Storage and handling
Information about safe storage and handling of the drug product.Other information ▪ each 5 mL contains: sodium 3 mg ▪ store at room temperature ▪ see bottom panel for lot number and expiration date ▪ protect from light ▪ contains low sodium
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 ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has ▪ a breathing problem such as chronic bronchitis ▪ glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product ▪ marked drowsiness may occur ▪ sedatives and tranquilizers may increase drowsiness ▪ excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).
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