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Diphenhydramine hcl - Medication Information

Product NDC Code 73376-003
Drug Name

Diphenhydramine hcl

Type Generic
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Diphenhydramine hydrochloride 25 mg/25mg
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 1049630
Application Number M012
Labeler Name INVAHEALTH INC
Packages
Package NDC Code Description
73376-003-80 1000 mg in 1 bottle (73376-003-80)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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.
take every 4 to 6 hours do not take more than 6 doses in 24 hours adults & children 12 years & over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use this product in children under 6 years of age

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 3, magnesium stearate, microcrystalline cellulose, polyethylene glycol, hydroxy propyl methyl cellulose 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.
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.
Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
Diphenhydramine HCl Diphenhydramine HCl CROSCARMELLOSE SODIUM FD&C RED NO. 3 TALC POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED 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.
Main label

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.
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.
taking sedatives or tranquilizers

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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
609-642-6380

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.
Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

Pregnancy or breast feeding

Pregnancy 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

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