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Sleepaid softgels - Medication Information

Product NDC Code 84324-011
Drug Name

Sleepaid softgels

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Diphenhydramine hydrochloride 50 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1020477
Application Number M010
Labeler Name NUVICARE LLC
Packages
Package NDC Code Description
84324-011-01 100 capsule, liquid filled in 1 bottle (84324-011-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (In Each Softgel) 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: 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: Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF.

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

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 Softgels Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE POLYETHYLENE GLYCOL, UNSPECIFIED GELATIN SORBITOL SORBITAN GLYCERIN FD&C BLUE NO. 1 cp71

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.
PL0210-00 NC-Sleep Aid Soft Gels-100ct

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 Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

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 an enlarged 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 Center right away. (1-800-222-1222)

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 (718) 337-8733 or visit: [email protected]

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 continuously for more than 2 weeks. 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 drinks

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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 between 15-30°C (59-86°F). Avoid high humidity. 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.
Do not use: for children under 12 years of age with any other 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

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