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| Product NDC Code | 57237-317 | ||||
|---|---|---|---|---|---|
| Drug Name | Diphenhydramine hcl oral solution |
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| Type | Brand | ||||
| 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 | M009.50 | ||||
| Labeler Name | Rising Pharma Holdings, 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 per 5 mL (1 Unit Dose) 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 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 2 years of age Do not use Children 2 to under 6 years of age Do not use unless directed by a doctor Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)
| age | dose |
|---|---|
| Children under 2 years of age | Do not use |
| Children 2 to under 6 years of age | Do not use unless directed by a doctor |
| Children 6 to under 12 years of age | 5 mL (12.5 mg) to 10 mL (25 mg) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and 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 respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
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 Oral Solution Diphenhydramine HCl Oral CITRIC ACID MONOHYDRATE FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SODIUM CITRATE SUCRALOSE 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.PRINCIPAL DISPLAY PANEL 12.5 mg/5 mL Case Label NDC 57237-317-51 Lid Label NDC 57237-317-05 Diphenhydramine-Case-lab Diphenhydramine-Lid-lab
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
Other information • each 5 mL contains sodium: 3 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • do not use if lid is torn or broken
Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 FG-35/Iss.: 10/2023
NDC Information - 12.5 mg/5 mL Each 5 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 12.5 mg and is supplied in the following oral dosage forms: NDC 57237-317-05: 5 mL unit dose cup NDC 57237-317-51: 100 x 5 mL Unit-Dose Cups
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 the child has • a breathing problem such as chronic bronchitis • glaucoma
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 the child is 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 • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin
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 accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
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 1-844-474-7464
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 • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children
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 Ask a doctor before use if the child has • a breathing problem such as chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
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