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| Product NDC Code | 54738-115 | ||||||||||
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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 | 1020477, 1049909 |
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| Application Number | part341 | ||||||||||
| Labeler Name | Richmond Pharmaceuticals 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 capsule) Diphenhydramine HCl 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 1 to 2 capsules every 4 to 6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor Other information store at 15-30°C(59-86°F) protect from moisture
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate
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 of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or 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.Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride BENZYL ALCOHOL BUTYLPARABEN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM LAURYL SULFATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE pink, natural AP;20 Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride BENZYL ALCOHOL BUTYLPARABEN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM LAURYL SULFATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE pink, pink AP;21
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.PRINCIPAL DISPLAY PANEL 215d1ac5-figure-01
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 215d1ac5-figure-02
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.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 glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis
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
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? call 804-270-4498 , 8:30 am - 4:30 pm ET, Monday – Friday TAMPER EVIDENT: DO NOT USE IF BLISTER PACK IS TORN OR DAMAGED *Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the trademark BENADRYL® Allergy. Distributed by: Richmond Pharmaceuticals Inc., Richmond, VA 23233 Made in USA RI1010 Principle Display Panel Richmond Pharmaceuticals, Inc. *Compare to active ingredient in BENADRYL® Allergy Diphenhydramine HCI Capsules, USP 25 mg 50 mg ANTIHISTAMINE 100 CAPSULES (10 x 10)
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 you may get very drowsy avoid alcoholic drinks alcohol, sedatives & 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 feedingIf 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 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