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All day allergy relief - Medication Information

Product NDC Code 59726-063
Drug Name

All day allergy relief

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Cetirizine hydrochloride 10 mg/1
Route ORAL
Dosage Form CAPSULE
RxCUI drug identifier 1014675
Application Number ANDA213105
Labeler Name P & L Development, LLC
Packages
Package NDC Code Description
59726-063-25 1 bottle in 1 box (59726-063-25) / 25 capsule in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each capsule) Cetirizine HCl 10 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 Adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65 years and over ask a doctor. Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor
Adults and children 6 years and overOne 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
Adults 65 years and over ask a doctor.
Children under 6 years of age ask a doctor
Consumers with liver or kidney disease ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol

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.
All Day Allergy Relief Cetirizine HCl CETIRIZINE HYDROCHLORIDE CETIRIZINE GELATIN GLYCERIN MANNITOL POLYETHYLENE GLYCOL 400 WATER SODIUM HYDROXIDE SORBITAN SORBITOL BUTYLATED HYDROXYTOLUENE Clear C10

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.
Product Label WELLNESS BASICS All Day Allergy Relief Cetirizine HCl 10 mg

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.
Principal Display Panel all-day allergy cetirizine HCI capsules 10 mg Antihistamine sofgels** (**liquid-filled capsules) indoor & outdoor allergies *Compare to the active ingredient in Zyrtec® *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec® TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: PL Developments 200 Hicks Street, Westbury, NY 11590

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 (1-800-222-1222) 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? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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 alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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 at 20 o - 25 o C (68 o to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F) protect from light

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.
Warning

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