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| Product NDC Code | 53942-522 | ||||
|---|---|---|---|---|---|
| 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 | LIQUID | ||||
| RxCUI drug identifier | 1248354 | ||||
| Application Number | M010 | ||||
| Labeler Name | DeMoulas Market Basket | ||||
| 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 ingredients DRUG FACTS (in each 30 mL dose cup or 2 tablespoons) 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 as recommended use dosage cup or tablespoon Age Dose Adults and children 12 years and over One dose = 2 tablespoons (30 mL) 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 citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin
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 reduces time to fall asleep if you have difficulty falling asleep for relief of occassional 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.Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID ACETATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLOXAMER 407 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM
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.Product Label *COMPARE TO THE ACTIVE INGREDIENT IN ZzzQuil™ NIGHTTIME SLEEP-AID Nighttime SLEEP-AID Diphenhydramine Non-Habit Forming Warming Berry Flavored Liquid No for treating Cold or Flu 12 FL OZ (354 mL) *This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark ZzzQuil™ . DISTRIBUTED BY DEMOULAS SUPERMARKETS INC. 875 EAST STREET TEWKSBURY, MA 01876 LR-053 Rev 01 DO NOT USE IF IMPRINT SHRINK BAND IS MISSING OR BROKEN Failure to follow these warnings could result in serious consequences res AptaPharmMB Sleep Aid 522
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 heart disease trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as asthma, emphysema or chronic bronchitis
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
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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each 30 mL dose (2 tablespoons) contains: sodium 23 mg dosage cup provided store at room temperature
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
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 sleepiness persists continuously for more than two 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 do not use more than directed avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness
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 for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
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