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| Product NDC Code | 67091-290 | ||||
|---|---|---|---|---|---|
| Drug Name | Sleep aid nighttime |
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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 | LIQUID | ||||
| Application Number | M012 | ||||
| Labeler Name | WinCo Foods, LLC | ||||
| 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) 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) - (see overdose warning) mL= milliliter keep dosing cup with product measure only with dosing cup provided do not use any other dosing device adults and children 12 years and over one dose=30 mL at bedtime if needed, or as directed by a doctor children under 12 years do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate
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.Sleep Aid NightTime Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID PROPYLENE GLYCOL POLYOXYL 40 STEARATE WATER SODIUM BENZOATE SACCHARIN SODIUM ANHYDROUS TRISODIUM CITRATE DIHYDRATE HIGH FRUCTOSE CORN SYRUP FD&C BLUE NO. 1 ALCOHOL FD&C RED NO. 40
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 *Compare to the active igredient in ZZZQUIL® NIGHTTIME Sleep Aid DIPHENHYDRAMINE HCI 50 mg / NIGHTTIME SLEEP-AID Not For Treating Cold or Flu Safe, Non-Habit Forming Alcohol 10% Berry Flavor FL OZ (mL) FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING . *This product is not manufactured or distributed byThe Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company. DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704 www.wincofoods.com
Package Label Winco Foods NightTime Sleep-Aid Berry Flavor Diphenhydramine HCI 50 mg
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.Other information each 30 mL contains : sodium 23 mg store at 20-25ºC (68-77ºF) do not refrigerate protect from light
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 asthma, emphysema, or chronic bronchitis glaucoma heart disease 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 or any other sleep-aid.
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 with any other product containing diphenhydramine, even one used on the skin for children under 12 years of age with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids
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: Taking more than directed can cause serious health problems. 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 to report an adverse event call 800-824-1706 Monday - Friday 9am - 4PM MST
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 drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness be careful when driving a motor vehicle or operating machinery
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 with any other product containing diphenhydramine, even one used on the skin for children under 12 years of age with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids Ask a doctor before use if you have a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma heart disease trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid. When using this product drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness be careful when driving a motor vehicle or operating machinery 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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