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| Product NDC Code | 55154-0683 | ||||
|---|---|---|---|---|---|
| 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 | 1049909 | ||||
| Application Number | M012 | ||||
| Labeler Name | Cardinal Health 107, LLC | ||||
| 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 banded capsule) 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 -Take every 4 to 6 hours – do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 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.Uses- 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. When using this product: • Marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children
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 D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED LACTOSE, UNSPECIFIED FORM STARCH, CORN 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 25 mg 10 Capsules bag 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Storage Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]. -protect from moisture -contains lactose Questions or comments? (800) 616-2471 Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 MFGD By CPC, NY 11788 Distributed By: Cardinal Health Dublin, OH 43017 L36150280122
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 products containing diphenhydramine, including one applied topically Ask a doctor before use if you have –glaucoma -a breathing problem such as emphysema or chronic bronchitis –difficulty in urination due to enlargement of the prostate gland This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. DO NOT USE IF BLISTER UNIT IS BROKEN
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