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| Product NDC Code | 81533-300 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nobleaid 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 | TABLET | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Noble OTC LLC | ||||||
| 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.Active Ingredients (in each caplet) Diphenhydramine HCl 25mg
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 • take every 4 to 6 hours, or as directed by the doctor • 24 hours • adults and children under 12 yrs old and over 1 to 2 caplets children 6 to 12 years of age 1 caplet under children 6 years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Colloidal silicon dioxide, Croscarmellose sodium, Stearic acid, Talc, Dicalcium phosphate, Polyethylene glycol, Magnesium stearate, Phloxine B Lake, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide
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: • itchy or watery eyes • runny nose • itchy nose or throat • sneezing • temporarily relieves these symptoms of the common cold: • sneezing • runny nose
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.NobleAid ALLERGY RELIEF Diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE CROSCARMELLOSE SODIUM STEARIC ACID TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE D&C RED NO. 27 MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE D25
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.Packaging pink-allergy relief
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
Experience fast relief from itchy, puffy, red or watery eyes typically caused by pet dander, hair, pollen, dust and hay fever. You don't have to suffer through allergy symptoms another day longer. Itchy eyes can negatively affect your vision, focus and even work performance. Diphenhydramine HCL helps reduce and relieve congestion of your nose, sinus and throat to help you breathe better and deeper. The antihistamine effects of this over the counter medication can help reduce the symptoms of the common cold like a runny nose, coughing or sneezing. Allergy symptoms can make your whole day miserable, but they can also affect your sleep. The antihistamine response may naturally cause drowsiness in both adults and kids, so it is often taken in the evening or before bed to help you fall asleep faster and stay asleep *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy. Manufactured for Noble OTC LLC 788 Convery Blvd, Perth Amboy NJ 08861 www.nobleotc.com
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.In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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? Please call (347)378-8990 Monday through Friday 9-5 or by Email [email protected]
Storage and handling
Information about safe storage and handling of the drug product.Other information Each caplet contains: Calcium 23.52 mg Store at controlled room temperature 20-25°C (68-77°F) Read all the product information before using TAMPER EVIDENT Do not use if safety seal under cap is broken or missing
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: • With any product containing diphenhydramine, even one used on skin • To make a child sleepy Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchi Ask a doctor or pharmacist before use if you are • taking sedative or tranquilizers When using this product • marked drowsiness may occur • avoid alcoholic drinks • excitability may occur especially in children • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machine If pregnant or breast-feeding, 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