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| Product NDC Code | 0363-7300 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | SOLUTION | ||||||
| Application Number | M010 | ||||||
| Labeler Name | WALGREEN COMPANY | ||||||
| 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 30 mL dose cup) 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 ▪ take only one dose per day (24 hours) ▪ only use the dose cup provided adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
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 the 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 Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE
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 - 354 mL Label Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid* Nighttime Sleep-aid Diphenhydramine HCl Non-Habit Forming Makes you fall asleep fast Alcohol-Free Cherry Vanilla Flavor Naturally and Artificially Flavor Not for Pain, Not for Colds, Just for Sleep 12 FL. OZ. (354 ml) *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 Walgreens.com ©2017 Walgreen Co. Package Label for Nighttime Sleep-Aid Package Label for Nighttime Sleep Aid Twin-Pack Nighttime Sleep Aid Dihenhydramine HCl Walgreen Nighttime Sleep-aid Diphenhydramine HCL
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
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 ▪ 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
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 ▪ for 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 at 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? 1-866-467-2748
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 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 beverages
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 • each 30 mL dose cup contains: potassium 5 mg; sodium 10 mg • store at room temperature
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 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 ▪ difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ▪ avoid alcoholic beverages 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222
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