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| Product NDC Code | 55681-322 | ||||
|---|---|---|---|---|---|
| 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 | ||||
| RxCUI drug identifier | 1049630 | ||||
| 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 tablet) 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, not more than 6 doses in 24 hours Adults and children 12 years of age and older: 1 or 2 tablets children 6 to under 12 years of age: 1 tablet children 4 to under 6 years of age: do not use unless directed by a doctor children under 4 years of age: 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, d&c red 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc
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 itchy nose or throat temporarily relieves these symptoms of the common cold: runny nose 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 D&C RED NO. 27 DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYVINYL ALCOHOL TALC TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE I3
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 ITEM# PCOTC124 Distributed by: ProCure Products Santa Fe Springs, CA 90670 MADE IN THE U.S.A. Allergy Relief
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 accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information each tablet contains : calcium 20 mg store at controlled room temperature 20°-25°C (68°-77°F). read all product information before using. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
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 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 with any other 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 bronchitis Ask a doctor or pharmacist before use if you are taking sedatives 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 machinery
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