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| Product NDC Code | 24689-154 | ||||
|---|---|---|---|---|---|
| Drug Name | Sleepaid (diphenhydramine hcl) |
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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 | APNAR PHARMA LP | ||||
| 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.DRUG FACTS Active ingredient (in each soft gel) 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: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink
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 Use for relief of 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.SleepAid (Diphenhydramine HCL) Diphenhydramine HCL FD&C BLUE NO. 1 GLYCERIN GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED SORBITAN WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SORBITOL AD1
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.NDC 24689-154-01 SleepAid Diphenhydramine HCL 50 mg Safe, non habit-forming One softgel per dose Made in USA 100 Soft gels SleepAid-Diphenhydramine HCL Capsule-50 mg-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.*Compare to active ingredient in Unisom ® SleepGels ® *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ® Rev.: 03/2023 Manufactured by: Apnar Pharma LLP East Windsor, NJ 08520
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 THE REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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? Call 1-855-642-2594
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 15º to 30º C (59º to 86º F) avoid excessive heat do not use if imprinted safety seal under 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 for children under 12 years of age with any other products containing diphenhydramine, even one used on skin. Ask a doctor before use if you have a breathing problem such as emphysema 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 product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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