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| Product NDC Code | 69452-451 | ||||
|---|---|---|---|---|---|
| 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 | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1020477 | ||||
| Application Number | M010 | ||||
| Labeler Name | BIONPHARMA 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 capsule) Diphenhydramine HCl 50 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 Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. swallow whole; do not crush, chew, or dissolve
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution
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 For relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
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 POLYETHYLENE GLYCOL 600 SORBITAN GELATIN POLYETHYLENE GLYCOL 400 WATER GLYCERIN PROPYLENE GLYCOL SORBITOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Clear Transparent DF50
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.120's count † Compare to the active ingredient in Unisom® SleepGels® NDC 69452-451-22 a+ health TM maximum strength nighttime sleep-aid dye free diphenhydramine HCl capsules USP, 50 mg • fall asleep fast • sleep soundly • safe, non-habit forming one softgel per dose 120 softgels ** **liquid-filled capsules front back
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.†This product is not manufactured or distributed by the owners of Unisom® SleepGels®. DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING. Manufactured for: Bionpharma Inc. Princeton, NJ 08540 Made in India Mfg. Lic. No.: TN00002123 L0000862 R0524 2620535 Lot No.: Exp. 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 difficulty in urination due to enlargement of the 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 sedatives or tranquilizers.
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 Centre 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? 1-888-235-2466 (Mon-Fri 9AM-5PM EST)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if sleeplessness persists continuosly for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
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 avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery
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 20 o C to 25 o C (68 o F to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F). protect from light
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 for children under 12 years of age with any product containing diphenhydramine, even one used on skin.
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