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| Product NDC Code | 0363-7100 | ||||
|---|---|---|---|---|---|
| Drug Name | Adult allergy relief dye free |
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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 | M012 | ||||
| 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.Drug Facts Active ingredient [in each 10 mL] Diphenhydramine HCl, USP 25 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 ▪ measure only with dosing cup provided ▪ Keep dosing cup with product ▪ mL = milliliter ▪ do not take more than 6 doses in 24 hours Age (yr) Dose (mL) Adult and children 12 years and older 10 mL to 20 mL (2 to 4 tsp) every 4 to 6 hrs Children under 12 years Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose 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 ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ sneezing ▪ itchy, watery eyes ▪ runny nose ▪ itching of the nose or throat
Purpose
Information about the drug product’s indications for use.Purpose Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Adult Allergy Relief Dye Free Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CHERRY GLYCERIN POTASSIUM CITRATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE Colorless to Pale Yellow
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 4 Fl Oz (118 Ml Bottle) NDC 0363-7100-04 Dye-Free Adult Allergy Relief Diphenhydramine HCl | Antihistamine For Relief of: • Runny nose • Itchy, watery eyes • Sneezing and Itchy Watery Eyes Sugar Free Cherry Flavor Naturally and Artificially Flavored 4 FL OZ (118 mL) † Our pharmacists recommend the Walgreens brand. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 Walgreens 100% SATISFACTION GURANTEED Walgreens.com @2021 Walgreens Co. IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING. Dye-Free Adult's Allergy Relief Diphenydramine HCl
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 chronic bronchitis ▪ glaucoma ▪ a sodium-restricted diet ▪ trouble urinating due to enlarged prostate 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 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children If 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 10 mL contains: sodium 6 mg • store at room temperature. Store in outer carton until contents used • do not refrigerate • see bottom panel for lot number and expiration date • protect from light • low sodium
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 ▪ to make a child sleepy ▪ 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