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| Product NDC Code | 63187-866 | ||||||||||
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| Drug Name | Diphenhydramine hcl |
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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 | ||||||||||
| 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(in each capsule) Diphenhydramine HCL 50 mg Purpose Antihistamine
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 4-6 hours • Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 capsule Children under 12 years ask a doctor **25 mg strength is not available in this package. Do not attempt to break capsules.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, 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 associated with the common cold, hay fever, or other respiratory allergies. • Sneezing. • Nasal congestion. • Runny nose. • 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 HCL Diphenhydramine HCL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FERROSOFERRIC OXIDE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE PH013
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.63187-866-30
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 have • Trouble urinating due to enlarged prostate gland • A breathing problem such as emphysema or chronic bronchitis • Glaucoma • 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 • With any other product containing Diphenhydramine HCL, including one applied topically.
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? Adverse drug event call: 1-800-687-0176
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 • Avoid alcoholic drinks. • Marked drowsiness may occur. • Excitability may occur, especially in children. • 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information: • Store at room temperature 15-30 degrees C (59-86 degrees F) • Protect from excessive moisture
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:
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