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| Product NDC Code | 57237-305 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Diphenhydramine oral liquid |
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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 | LIQUID | ||||||
| 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 in each 5 mL ( in one teaspoonful) 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 Do not use more than 6 dose in 24 hours adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg) children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg) children under 6 years ask a doctor
| adults and children 12 years of age and over | 2 to 4 teaspoonfuls (25 to 50 mg) |
| children 6 to under 12 years of age | 1 to 2 teaspoonfuls (12.5 to 25 mg) |
| children under 6 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water. Questions or comments? 1-844-474-7464
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 Oral Liquid Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Anhydrous Citric Acid D&C RED NO. 33 FD&C RED NO. 40 Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol Sucrose Water dark pink to pink
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 Rising Health, LLC NDC 57237-305-12 Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution 4 fl oz (118 mL) diphenhydramine-label
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
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 trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis. a sodium-restricted diet
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 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 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 overdose, get medical help or contact a Poison Control Center right away.
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 15º - 30ºC (59º - 86ºF) protect from freezing protect from light each teaspoon (5 mL) contains: sodium 8 mg TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
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. Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis. a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. 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. 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 right away. Directions take every 4-6 hours Do not use more than 6 dose in 24 hours adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg) children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg) children under 6 years ask a doctor
| adults and children 12 years of age and over | 2 to 4 teaspoonfuls (25 to 50 mg) |
| children 6 to under 12 years of age | 1 to 2 teaspoonfuls (12.5 to 25 mg) |
| children under 6 years | ask a doctor |
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