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| Product NDC Code | 50488-4125 | ||||
|---|---|---|---|---|---|
| Drug Name | Diphenhydramine hcl 12.5mg antihistamine |
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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 | BAR, CHEWABLE | ||||
| RxCUI drug identifier | 1049900 | ||||
| Application Number | part341 | ||||
| Labeler Name | Alexso, Inc | ||||
| 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 soft chew) Diphenhydramine HCl 12.5mg
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 Adults and children 12 years and over: Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor Do not take more than 6 times in 24 hours Chew each soft chew thoroughly before swallowing Children 6 to 11 years: Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor. Do not take more than 6 times in 24 hours Chew each soft chew thoroughly before swallowing Children under 6 years: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: citric acid, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, mineral oil, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.
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 Itchy, watery eyes Sneezing Itching of the nose or throat
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.Diphenhydramine HCl 12.5mg Antihistamine Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE ANHYDROUS DEXTROSE HYDROXYPROPYL BETADEX MAGNESIUM STEARATE MALTITOL MALTODEXTRIN MINERAL OIL NEOTAME WATER CARRAGEENAN SODIUM CHLORIDE STARCH, CORN CORN SYRUP SUCRALOSE SUCROSE TRISODIUM CITRATE DIHYDRATE Light yellow to golden brown
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 Diphenhydramine HCl 12.5 mg Soft Chews 20 Bubble Gum Flavored Gummies Chewy Gummy Bites NDC: 50488-4125-1 Patent Pending Diphenhydramine HCl 12.5 mg Soft Chews 20 Bubble Gum Flavored Gummies Chewy Gummy Bites NDC:50488-4125-1 Patent Pending
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.Diphenhydramine HCl 12.5 mg Soft Chews Alexso, Inc. ---------------- Diphenhydramine HCl 12.5 mg Soft Chews DRUG FACTS
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 A breathing problem such as emphysema or chronic bronchitis Glaucoma Trouble urinating due to an enlarged prostate gland
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 you are 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 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 (1-800-222-1222) 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 or comments? Call 888-495-6078
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 Excitability may occur, especially in children Marked drowsiness may occur Avoid alcoholic drinks Alcohol, sedatives, and tranquilizers may increase drowsiness 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Diphenhydramine 12.5mg Soft Chews is supplied in the following dosage form: Twenty (20) Soft Chews per container ***Made in USA*** Manufactured for: Alexso, Inc. 2317 Cotner Ave Los Angeles, CA 90064 NDC: 50488-4125-1 Size: 20 Soft Chews
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION each soft chew contains: sodium 7 mg . Very low sodium. store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing.
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 child sleepy With any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have A breathing problem such as emphysema or chronic bronchitis Glaucoma Trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid alcoholic drinks Alcohol, sedatives, and tranquilizers may increase drowsiness 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 (1-800-222-1222) 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