NDC 0121-0978 Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

NDC Product Code 0121-0978

NDC 0121-0978-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10)

NDC Product Information

Diphenhydramine Hydrochloride with NDC 0121-0978 is a a human prescription drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Diphenhydramine Hydrochloride is diphenhydramine hydrochloride. The product's dosage form is solution and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Diphenhydramine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)
  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
FDA Application Number: ANDA087513 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-10-1982 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

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Diphenhydramine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx ONLY

Nighttime Sleep-aid.

Pharmaceutical Associates, Inc.Greenville, SC 29605


www.paipharma.comR10/16

Description

Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N,N -dimethylethylamine hydrochloride and has the molecular formula C


17H


21NO•HCI (molecular weight 291.82). It occurs as a white odorless, crystalline powder and is freely soluble in water and alcohol. The structural formula is as follows:


Each 5 mL contains 12.5 mg of diphenhydramine hydrochloride and alcohol 14% for oral administration.  Inactive Ingredients:  Citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, purified water, sodium citrate, and sucrose.

Clinical Pharmacology

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours. Diphenhydramine is widely distributed throughout the body, including the CNS. Little, if any, is excreted unchanged in the urine; most appears as the degradation products of metabolic transformation in the liver, which are almost completely excreted within 24 hours.

Indications And Usage

Diphenhydramine hydrochloride in the oral form is effective for the following indications:

Antihistaminic

For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions


adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Motion Sickness

For active and prophylactic treatment of motion sickness.

Antiparkinsonism

For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents.

Use In Neonates Or Premature Infants

This drug should


not be used in neonates or premature infants.

Use In Nursing Mothers

Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Antihistamines Are Also Contraindicated In The Following Conditions

Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

Warnings

Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.

Use In Pediatric Patients

In pediatric patients, especially, antihistamines in


overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation.

Use In The Elderly (Approximately 60 Years Or Older)

Antihistamines are most likely to cause dizziness, sedation, and hypotension in elderly patients.

General

Diphenhydramine hydrochloride has an atropine-like action and therefore, should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Use with caution in patients with lower respiratory disease including asthma.

Information For Patients

Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Drug Interactions

Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric Use

Diphenhydramine hydrochloride should not be used in neonates and premature infants (see


CONTRAINDICATIONS).


Diphenhydramine hydrochloride may diminish mental alertness, or, in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions, or death (see


WARNINGS and


OVERDOSAGE).


See also


DOSAGE AND ADMINISTRATION section.

Adverse Reactions

  • The most frequent adverse reactions are underscored.General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose and throat.
  • Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.
  • Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
  • Nervous System: Sedation,sleepiness,dizziness,disturbedcoordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.
  • GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
  • GU System: Urinary frequency, difficult urination, urinary retention, early menses.
  • Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness.

Overdosage

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur.If vomiting has not occurred spontaneously, the patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precaution against aspiration must be taken, especially in infants and children.


If vomiting is unsuccessful, gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic or 1/2 isotonic saline is the lavage solution of choice.


Saline cathartics, as milk of magnesia, by osmosis draw water into the bowel and therefore are valuable for their action in rapid dilution of bowel content.


Stimulants should not be used.


Vasopressors may be used to treat hypotension.

Dosage And Administration

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours.

Adults

25 to 50 mg three or four times daily. The nighttime sleep-aid dosage is 50 mg at bedtime.

Pediatric Patients, Other Than Premature Infants And Neonates

12.5 to 25 mg three or four times daily. Maximum daily dosage not to exceed 300 mg. For physicians who wish to calculate the dose on the basis of body weight or surface area, the recommended dosage is 5 mg/kg/24 hours or 150 mg/m


2/24 hours.


Data are not available on the use of diphenhydramine hydrochloride as a nighttime sleep-aid in children under 12 years.The basis for determining the most effective dosage regimen will be the response of the patient to medication and the condition under treatment.In motion sickness, full dosage is recommended for prophylactic use, the first dose to be given 30 minutes before exposure to motion and similar doses before meals and upon retiring for the duration of exposure.

Storage

Keep tightly closed. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing and light.

How Supplied

Each 5 mL of Diphenhydramine Hydrochloride Oral Solution USP (purple/red color, cinnamon/anise flavor) contains 12.5 mg diphenhydramine hydrochloride with 14% alcohol and is supplied in the following oral dosage forms:


NDC 0121-0489-05:  5mL unit dose cupNDC 0121-0489-00:  Case contains 100 unit dose cups of 5mL (0121-0489-05) packaged in 10 
trays of 10 unit dose cups each.NDC 0121-0978-10:  10mL unit dose cupNDC 0121-0978-00:  Case contains 100 unit dose cups of 10mL (0121-0978-10) packaged in 10 
trays of 10 unit dose cups each.

* Please review the disclaimer below.