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| Product NDC Code | 71679-106 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | Health Pharma USA 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 doses in 24 hours Adults and children 12 years and over:1 or 2 caplets Children 6 to under 12 years :1 caplet Children under 6 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients May Contains: Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Magnesium Stearate, film coaat AMB pink, Polyethylene Glycol, Polyvinyl Alcohol, Phloxine B lake, 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: 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 ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM STEARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED D&C RED NO. 28 TITANIUM DIOXIDE TALC DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Diphenhydramine Hydrochloride 25 mg/Antihistamine Compare to Benadryl ® Allergy active ingredients* *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl ® Allergy. 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 accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Each caplet contains: Calcium 23.52 mg Store between 20-25°C (68-77°F) Protct from light TAMPER EVIDENT: DO NOT USE IF 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? Call 1-844-832-1138 9 AM- 4 PM Monday - Friday
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