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| Product NDC Code | 84447-103 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | SOLUTION | ||||||||
| RxCUI drug identifier | 1049906 | ||||||||
| Application Number | M012 | ||||||||
| Labeler Name | Belleview Biosciences | ||||||||
| 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 tsp) Diphenhydramine HCL, 12.5 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 4-6 hours, or as directed by doctor. * Do NOT exceed the recommended dose Age Dose Adults and Children 12 years of age and over take 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours Children 6 to under 12 years of age take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours Children under 6 years of age Consult a doctor
| Age | Dose |
| Adults and Children 12 years of age and over | take 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours |
| Children 6 to under 12 years of age | take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours |
| 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, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose
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: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat ■ Temporarily relieves these symptoms due to the common cold: ■ runny nose ■ sneezing
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 AMMONIUM GLYCYRRHIZATE POTASSIUM CITRATE METHYLPARABEN PROPYLENE GLYCOL SUCRALOSE PROPYLPARABEN SORBITOL ANHYDROUS CITRIC ACID WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE
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.Drug Facts Bulk 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 ■ to make a child sleepy Ask a doctor before use if you have: ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ trouble urinating due to the enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product: ■ excitability might occur, especially in children ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness effect ■ be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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