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Sleep aid - Medication Information

Product NDC Code 72090-020
Drug Name

Sleep aid

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Diphenhydramine hydrochloride 25 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 1049630
Application Number M010
Labeler Name Pioneer Life Sciences, LLC
Packages
Package NDC Code Description
72090-020-10 100 tablet in 1 bottle (72090-020-10)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each caplet) Diphenhydramine HCl 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 ■ do not take more than directed (See overdose warning) ■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor ■ children under 12 years: do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.

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 Night Time Sleep Aid

Spl product data elements

Usually a list of ingredients in a drug product.
Sleep Aid Diphenhydramine HCl 25 mg SILICON DIOXIDE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C BLUE NO. 1 FD&C BLUE NO. 2 LECITHIN, SOYBEAN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TALC DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE S5

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.
PRINCIPAL DISPLAY PANEL Sleep-Aid-Regular Strength-100ct

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 Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
OTHER INFORMATION ■each caplet contains: calcium 23.52 mg ■store between 15-30°C (59-86°F). ■Avoid high humidity. ■ Protect from light.

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 1-732-698-5070 M on to Fri 9am – 5pm.

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 persist 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 ■ drowsiness will occur ■ do not drive a motorvehicle or operate machinery.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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.

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