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| Product NDC Code | 80136-785 | ||||
|---|---|---|---|---|---|
| Drug Name | Nighttime sleep-aid |
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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 | TABLET | ||||
| RxCUI drug identifier | 1049630 | ||||
| Application Number | M010 | ||||
| Labeler Name | NORTHEAST PHARMA | ||||
| 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 caplet) Diphenhydramine Hydrochloride 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.Directions • adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor • do not exceed recommended dose
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients calcium phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silica.
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 relieves occasional sleeplessness
Purpose
Information about the drug product’s indications for use.Purpose Nighttime Sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.Nighttime Sleep-aid Diphenhydramine HCl SILICON DIOXIDE CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 93XF;57344
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.package label 1
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.
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? 1-800-540-3765
Storage and handling
Information about safe storage and handling of the drug product.Other information each caplet contains: calcium 85mg store at 20°C-25°C (68°F-77°F) Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
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 children under 12 years • with any other product containing diphenhydramine, including one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema, asthma, or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this produc t • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. 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.
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