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Equaline childrens all day allergy - Medication Information

Product NDC Code 41163-475
Drug Name

Equaline childrens all day allergy

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Cetirizine hydrochloride 5 mg/5ml
Route ORAL
Dosage Form SOLUTION
RxCUI drug identifier 1014673
Application Number ANDA204226
Labeler Name United Natural Foods, Inc. dba UNFI
Packages
Package NDC Code Description
41163-475-26 1 bottle in 1 carton (41163-475-26) / 118 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each 5 mL) Cetirizine HCl 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 • use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • store between 20° to 25°C (68° to 77°F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date
adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose Questions or comments? 1-877-932-7948

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.
Equaline childrens all day allergy Cetirizine HCl CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS CITRIC ACID PROPYLENE GLYCOL 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.
Package/Label Principal Display Panel compare to Children’s Zyrtec ® active ingredient EQUALINE ® children’s all day allergy cetirizine hydrochloride oral solution 1 mg/mL (antihistamine) indoor & outdoor allergies 24 hour relief of: sneezing runny nose itchy, watery eyes itchy throat or nose DYE FREE – SUGAR FREE 2 years & older grape flavor dosing cup included 4 FL OZ (118mL) Equaline Children's All Day Allergy image

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 liver or kidney disease. Your doctor should determine if you need a different dose.

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 tranquilizers or sedatives.

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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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)

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? 1-877-932-7948

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 an allergic reaction to this product occurs. Seek medical help 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 • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information • store between 20° to 25°C (68° to 77°F) • do not use if carton is opened, or if printed neckband is broken or missing • 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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use.

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