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Product NDC Code | 41250-738 | ||||
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Drug Name | Meijer nighttime sleep-aid berry flavor |
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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 | ||||
RxCUI drug identifier | 1248354 | ||||
Application Number | M010 | ||||
Labeler Name | MEIJER DISTRIBUTION INC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts 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) ▪ measure with dosing cup provide adults & children 12 yrs & over One Dose = 30 mL at bed time if needed or as directed by a doctor Children under 12 yrs do not use Other information • each 30 mL dose contains: sodium 23 mg • store at room temperature • protect from light. Does not meet USP requirement for light-resistant packaging.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, FD&C Blue #1, FD&C Red #40, glycerin, natural and artificial flavor, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum. Questions or comments? 1-866-467-2748
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.Meijer Nighttime Sleep-aid Berry Flavor 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 XANTHAN GUM
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.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle) meijer ® NDC# 41250-738-12 Compare to Zzzquil ® Nighttime Sleep-Aid* active ingredient* Nighttime Sleep-aid Diphenhydramine HCl 50 mg • Non-Habit Forming Alcohol-Free Not for treating Cold or Flu, See Warnings Berry Flavor Naturally and Artificially Flavored 12 FL OZ (354 mL) MEIJER PHARMACIST RECOMMENED MONEY BACK GURANTEE DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark ZzzQuil®. meijer nighttime sleep-aid diphenhydramine HCl 50 mg
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 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 two 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
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).
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
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
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