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| Product NDC Code | 50486-616 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sleepinal |
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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 | ||||||
| Application Number | M010 | ||||||
| Labeler Name | Blairex Laboratories, 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 hydrochloride 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 and over: take 1 capsule 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 no. 1, FD&C red no. 3, gelatin, lactose, magnesium stearate, talc Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA
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.Use for relief of occasional sleeplessness.
Purpose
Information about the drug product’s indications for use.Purpose night-time sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.Sleepinal diphenhydramine hydrochloride LACTOSE MONOHYDRATE TALC MAGNESIUM STEARATE GELATIN FD&C BLUE NO. 1 FD&C RED NO. 3 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE transparent CAPSULE SLEEPINAL;
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.MAXIMUM STRENGTH Sleepinal ® Night-time Sleep-Aid CAPSULES NDC 50486-616-32 Non-habit Forming One Capsule Dosage Wake Up Refreshed 32 Capsules Diphenhydramine Hydrochloride PACKAGE NOT CHILD RESISTANT Principal Display Panel
MAXIMUM STRENGTH Sleepinal ® Night-time Sleep-Aid CAPSULES NDC 50486-616-16 Non-habit Forming One Capsule Dosage Wake Up Refreshed 16 Capsules Diphenhydramine Hydrochloride Principal Display Panel
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
Other information store at 15-30°C (59-86°F) protect from excessive moisture protect from light retain product in box until administered
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 a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to the 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 tranquilizers or sedatives
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 in children under 12 years of age. 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.
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 TOLL FREE 1-800-252-4739 www.sleepinal.net Telephone
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 doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 drinks.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 of age. with any other product 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 the enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives When using this product avoid alcoholic drinks. Stop use and ask 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. 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