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| Product NDC Code | 69339-151 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | M012 | ||||||
| Labeler Name | Natco Pharma USA 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 5 mL) Diphenhydramine HCl USP 12.5 mg
Active ingredient (in each 10 mL) Diphenhydramine HCl USP 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 • Use the following dosage guidelines when using this product Age (yr) Dose (mL) Adults and children 12 years and older take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours. Children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours Children under 6 years ask a doctor
| Age (yr) | Dose (mL) |
|---|---|
| Adults and children 12 years and older | take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours. |
| Children 6 years to under 12 years | take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours |
| Children under 6 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, D&C Red No. 33, FD&C Red No. 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, and sucrose.
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 • itchy 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 hydrochloride ANHYDROUS CITRIC ACID GLYCERIN WATER SUCROSE SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM D&C RED NO. 33 FD&C RED NO. 40 POLOXAMER 407 SODIUM CHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Diphenhydramine HCl Oral Solution diphenhydramine hydrochloride ANHYDROUS CITRIC ACID GLYCERIN WATER SUCROSE SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM D&C RED NO. 33 FD&C RED NO. 40 POLOXAMER 407 SODIUM CHLORIDE 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 Delivers 5 mL NDC 69339-151-05 Diphenydramine HCl Oral Solution, USP 12.5 mg/5 mL For Institutional Use Only 3 69339 15105 1 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel
PRINCIPAL DISPLAY PANEL Delivers 10 mL NDC 69339-152-01 Diphenydramine HCl Oral Solution, USP 25 mg/10 mL For Institutional Use Only 3 69339 15201 0 Lot # 000000 Exp: MM/YYY See Insert DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE Principal Display Panel
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 5mL contains sodium 10mg • each 10mL contains sodium 20mg • alcohol free, cherry flavor • store at 20-25°C (68-77°F) • protect from excessive moisture • do not use if lid seal is open or damaged • see top of cup for lot number and expiration date
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 you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to enlarged prostate gland
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 are taking tranquilizers or sedatives
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 • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy
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 (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 201-786-6500 Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DP-UD-PI-AT-[117894] Rev 08/20
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 • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How Supplied Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-151-05 (1) unit dose cup 5mL NDC 69339-151-17 40 (4x10) unit dose cups 5mL NDC 69339-151-19 100 (10x10) unit dose cups 5mL Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-152-01 (1) unit dose cup 10mL NDC 69339-152-17 40 (4x10) unit dose cups 10mL NDC 69339-152-19 100 (10x10) unit dose cups 10mL
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 • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Keep out of reach of children. In case of 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