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| Product NDC Code | 51824-056 | ||||
|---|---|---|---|---|---|
| Drug Name | Careall diphenhydramine |
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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, COATED | ||||
| RxCUI drug identifier | 1049630 | ||||
| Application Number | M012 | ||||
| Labeler Name | New World Imports, 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 Diphenhydramine HCl 25mg
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 Take every 4 to 6 hours, or as directed by a doctor. Do not take more than 6 times in 24 hours Adults and children 12 years of age and older : 1 to 2 caplets Children 6 to 12 years: 1 caplet Children under 6: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium 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 Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat Temporarily relieves these symptoms associated with the common cold: Sneezing, runny 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.CAREALL Diphenhydramine Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE CROSCARMELLOSE SODIUM D&C RED NO. 27 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM Magnesium Stearate Cellulose, Microcrystalline POLYETHYLENE GLYCOL, UNSPECIFIED Silicon Dioxide Titanium Dioxide Bright Pink Oval in Shape, sides straight, top and bottom rounded 048;D
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.DHC25 Label
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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.
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 with any other products containing diphenhydramine, including ones 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: Marked drowsiness may occur Avoid alcoholic beverages Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery Excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use
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