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Product NDC Code | 69842-719 | ||||
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Drug Name | Childrens allergy relief |
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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 | 1049906 | ||||
Application Number | M012 | ||||
Labeler Name | CVS PHARMACY | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 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 do not take more than directed find right dose on chart below mL = milliliter only use the dose cup provided take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL
children under 2 years | do not use |
children 2 to 5 years | do not use unless directed by a doctor |
children 6 to 11 years | 5 mL to 10 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum
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: runny nose sneezing itchy, watery eyes 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.Childrens Allergy Relief Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CHLORIDE TRISODIUM CITRATE DIHYDRATE 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.Principal display panel ♥CVS Health ® Compare to the active ingredient in Children’s Benadryl® Allergy* Dye Free Liquid Children’s Allergy Relief LIQUID MEDICATION DIPHENHYDRAMINE HCl 12.5 mg per 5 mL ORAL SOLUTION Antihistamine DYE FREE Relief of: • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat Cherry Flavored Sugar & Alcohol Free Ages 6 to 11 Years Actual Bottle Size on Side Panel 8 FL OZ (237 mL) Package Contains One Bottle Actual Size Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-18615 CVS ® Quality Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Benadryl® Allergy. 50844 REV0123B01719 CVS 44-017 CVS 44-017
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 the child has a breathing problem such as chronic bronchitis glaucoma
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 the child is 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 to make a child sleepy 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.
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? 1-800-426-9391
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 sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children
Storage and handling
Information about safe storage and handling of the drug product.Other information each 5 mL contains: sodium 4 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
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 Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of reach of children. 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