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| Product NDC Code | 81033-003 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | LIQUID | ||||||
| RxCUI drug identifier | 1049906 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Kesin Pharma Corporation | ||||||
| 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 5 mL) Diphenhydramine HCl 12.5mg
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 of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS citric acid, glycerin, propylene glycol, water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum, mixed berry flavor, strawberry flavor
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 For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.
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 TRISODIUM CITRATE DIHYDRATE WATER SORBITOL SUCRALOSE XANTHAN GUM DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL SODIUM BENZOATE Mixed Berry
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 [ Barcode ] NDC 81033-003-05 Diphenhydramine HCl Oral Solution Delivers 12.5mg / 5 mL 12.5mg / 5 mL Store at 68° - 77° F [ Lot # Exp Date ] PKG by Kesin Pharma Phoenix, AZ Sugar, Alcohol, Dye Free For Institutional Use Only [Barcode] [Barcode] NDC 81033-003-10 Diphenhydramine HCl Oral Solution Delivers 25mg / 10 mL 12.5mg / 5 mL Store at 68° - 77° F [Lot #] PKG by [Exp Date] Kesin Pharma Phoenix, AZ Sugar, Alcohol, Dye Free For Institutional Use Only [Barcode] DPH 5ml_UDC_final2.jpg DPH 10ml_UDC_final2.jpg
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
HOW SUPPLIED • NDC 81033-003-05 (12.5mg) unit dose cup • NDC 81033-003-10 (25 mg) unit dose cup
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 our of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION • each 5 mL contains: 16mg of sodium • store at 20°-25°C (68°-77°F) • tamper evident: DO NOT use if foil on cup is missing or torn • Alcohol Free, Dye Free, Sugar Free • NDC 81033-003-05 (12.5mg) unit dose cup • NDC 81033-003-10 (25 mg) unit dose cup
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 1-833-537-4679
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 • this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland Ask a doctor before use if your child has • a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet Ask a doctor or pharmacist before use if the child is • taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfin When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children • avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. Keep our of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin • this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if your child has • a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet
Ask a doctor or pharmacist before use if the child is • taking sedatives or tranquilizers
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfin
When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children • avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
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