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Product NDC Code | 69842-981 | ||||
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Drug Name | Diphenhydramine hydrochloride |
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Type | Generic | ||||
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, FILM COATED | ||||
RxCUI drug identifier | 1049630 | ||||
Application Number | part341 | ||||
Labeler Name | CVS Pharmacy, Inc | ||||
Packages |
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Overdosage of Diphenhydramine Hydrochloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts 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, or as directed by a doctor ■ Do not take more than 6 times in 24 hours Adults and children 12 years and over 1 to 2 tablets Children 6 to under 12 years 1 tablet Children under 6 years do not use
Adults and children 12 years and over | 1 to 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.Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Silica, Stearic Acid, Talc, Titanium Dioxide and Triacetin
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 ■ Temporarily relieves these symptoms due to 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.Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE MAGNESIUM STEARATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE TRIACETIN STEARIC ACID TALC TITANIUM DIOXIDE HYPROMELLOSES CROSCARMELLOSE SODIUM LIGHT MINERAL OIL CPC;2824
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.CVS Health Compare to the active ingredient in Benadryl® Allergy LIQUIGELS®* Allergy Relief Diphehydramine HCl, 25 mg Antihistamine Relief of: Sneezing; Runny nose; Itchy,watery eyes; Itchy throat 200 Tablets CVS Label
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.*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy LIQUIGELS®. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2020 CVS/pharmacy CVS.com® 1-800-SHOP CVS Product of China V-34601
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 ■ A breathing problem such as emphysema or chronic bronchitis ■ Glaucoma ■ Trouble urinating due to an enlarged prostate gland
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 sedatives or tranquilizers.
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 ■ To make a child sleepy ■ With any other product containing diphenhydramine, even one used on skin
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.
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 37 mg ■ Store between 20-25° C (68-77° F). Protect from light.
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? 1-800-231-4670
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 ■ Marked drowsiness may occur ■ Avoid alcoholic drinks ■ Alcohol, sedatives, and tranquilizers may increase drowsiness ■ Be careful when driving a motor vehicle or operating machinery ■ Excitability may occur, especially in children
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.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 ■ A breathing problem such as emphysema or chronic bronchitis ■ Glaucoma ■ Trouble urinating due to an enlarged prostate gland 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 ■ Alcohol, sedatives, and tranquilizers may increase drowsiness ■ Be careful when driving a motor vehicle or operating machinery ■ Excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. 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.
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