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| Product NDC Code | 80136-683 | ||||
|---|---|---|---|---|---|
| Drug Name | Allergy relief |
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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 | NORTHEAST PHARMA | ||||
| 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) 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 do not exceed recommended dose adults and children 12 years and over, take 1 to 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours, or as directed by a doctor children under 12 years: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cellulose, D&C red #27 lake, dicalcium phosphate, magnesium stearate, PEG, polyvinyl alcohol, silica, starch, stearic acid, talc, 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 and other upper respiratory allergies: runny nose sneezing itching of the nose and throat itchy, watery eyes
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.Allergy relief Diphenhydramine HCl STEARIC ACID POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS SILICON DIOXIDE D&C RED NO. 27 CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE TALC 44;329
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 1
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 or comments? 1-800-540-3765
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: calcium 30 mg store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) protect from moisture Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
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 you have glaucoma difficulty urinating due to an enlarged prostate gland a breathing problem such as chronic bronchitis or emphysema 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 beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution 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