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| Product NDC Code | 55681-323 | ||||
|---|---|---|---|---|---|
| Drug Name | 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 | TWIN MED 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 ingredient (in each caplet) Diphenhydramine HCl 25 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 take every 4 to 6 hours, or as directed by a doctor do not take not more than 6 times in 24 hours adults and children 12 years and over: 1 or 2 tablets children 6 to under 12 years: 1 tablet children under 6 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, Magnesium stearate, Microcrystalline cellulose, Phloxine B lake, Polyethylene glycol, Polyvinyl alcohol, Stearic acid, Talc, 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: o runny nose o sneezing o itchy, watery eyes o itchy nose or throat temporarily relieves these symptoms of the common cold: o runny nose o sneezing
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.Allergy Relief Diphenhydramine Hydrochloride SILICON DIOXIDE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE D&C RED NO. 28 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STEARIC ACID TALC TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D25 Caplet
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 NDC 55681-323-03 Compare to active ingredients of Benadryl ® Allergy Tablets* ALLERGY RELIEF DIPHENHYDRAMINE HCl ANTIHISTAMINE *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl ® Allergy ULTRATAB ® Tablets. ITEM#PCOTC124 Distributed by: Twin Med LLC Santa Fe Springs, CA 90670 www.procureproducts.com MADE IN THE U.S.A label
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information protect from moisture store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? call toll-free 1-844-912-4012
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
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 you have trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis Ask your doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
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