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Cvs health childrens allergy relief - Medication Information

Product NDC Code 59779-793
Drug Name

Cvs health childrens allergy relief

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Diphenhydramine hydrochloride 12.5 mg/5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 1049906
Application Number part341
Labeler Name CVS Pharmacy,Inc.
Packages
Package NDC Code Description
59779-793-10 10 vial, single-dose in 1 carton (59779-793-10) / 5 ml in 1 vial, single-dose
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each 5 mL blister) Diphenhydramine HCl USP 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 • find right dose on chart below • break tab on blister • pour liquid directly into mouth or into teaspoon • be careful of blister edges to prevent cuts on skin • take every 4 to 6 hours • do not take more than 6 doses in 24 hours Age (yr) Dose (tsp) 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 1 to 2 single-dose blisters(12.5mg to 25mg)
Age (yr) Dose (tsp)
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 1 to 2 single-dose blisters(12.5mg to 25mg)

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.

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.
CVS Health Childrens Allergy Relief Diphenhydramine hydrochloride Diphenhydramine hydrochloride diphenhydramine anhydrous citric acid CARBOXYMETHYLCELLULOSE SODIUM glycerin POTASSIUM CITRATE water sodium benzoate sorbitol SUCRALOSE

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® * Dye-Free Liquid Children’s Allergy Relief Liquid Medication DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg Antihistamine alcohol and sugar free Relief of: Sneezing; runny nose; itchy, watery eyes; itchy throat Cherry Flavored Sugar & Alcohol free Actual Product size on Side Panel Single Dose 10 SINGLE DOSE VIALS This is not a child-resistant package. Keep out of reach of children *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Benadryl® Dye –Free Allergy. TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL SINGLE-DOSE BLISTER UNIT IS BROKEN OR OPEN Distributed by: CVS Pharmacy, Inc. One CVS Drive,Woonsocket, RI 02895 © 2015CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in the U.S.A. V-12431 CVS Quality Money Back Guarantee SNAP BACK AT PERFORATION LINE POUR INTO MOUTH OR SPOON Use scissors to cut blister if difficult to open. CVS Health Children's Allergy Relief 10 Single Dose Vials
TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL SINGLE-DOSE BLISTER UNIT IS BROKEN OR OPEN
Use scissors to cut blister if difficult to open.

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.
Drug Facts

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. (1-800-222-1222)

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 blister contains: sodium 11 mg • store at (59-77°F) • do not use if individual single-dose blisters are torn or broken • see bottom panel for lot number and expiration date

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. (1-800-222-1222)

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