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| Product NDC Code | 63187-771 | ||||||||||
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| Drug Name | Diphenhydramine hydrochloride |
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| Type | Generic | ||||||||||
| 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 | CAPSULE | ||||||||||
| RxCUI drug identifier | 1049909 | ||||||||||
| Application Number | M012 | ||||||||||
| Labeler Name | Proficient Rx LP | ||||||||||
| 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 Hydrochloride 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 Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours, not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours. Children under 6 years of age: do not use **12.5mg dosage strength is not available in this package. Do not attempt to break capsule
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.
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.Use Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and 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.Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE LACTOSE, UNSPECIFIED FORM STARCH, CORN GELATIN, UNSPECIFIED SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 MAGNESIUM STEARATE D&C RED NO. 28 CPC;835
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 CAPSULES 25MG 63187-771-20
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.Other information Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature]. Protect from excessive moisture.
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
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 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? Questions or comments? (800) 616-2471 Distributed by MAJOR® PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Re-Order No. 301574
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 • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy/breast-feeding warning If pregnant or breast-feeding, ask a health professional before use.
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
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