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| Product NDC Code | 70692-784 | ||||
|---|---|---|---|---|---|
| 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 | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1049909 | ||||
| Application Number | M010 | ||||
| Labeler Name | Strive Pharmaceuticals Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Diphenhydramine Hydrochloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Diphenhydramine HCl 25mg
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.do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 softgels at bedtime if needed or as directed by doctor children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water.
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.helps fall asleep faster for relief of occasional sleeplessness
Purpose
Information about the drug product’s indications for use.Sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride WATER FD&C BLUE NO. 1 SORBITAN POLYETHYLENE GLYCOL 400 SORBITOL PROPYLENE GLYCOL GLYCERIN GELATIN, UNSPECIFIED POVIDONE K30 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C RED NO. 40 784 Oblong
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.784
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.store at room temperature between 20-25°C (68-77ºF). avoid excessive heat, cold and humidity. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
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.Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and night-time cold/flu products Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as asthma, emphysema or chronic bronchitis heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid When using this product drowsiness may occur avoid alcoholic drinks and other drugs that cause drowsiness Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use.
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