DIPHEN- diphenhydramine hydrochloride solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Foxland Pharmaceuticals, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Diphenhydramine hydrochloride in the oral form is effective for the following indications: 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. For active and prophylactic treatment of motion sickness. 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. Nighttime Sleep-aid. This drug should not be used in neonates or premature infants. Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing
Product summary:
Each 5mL of Diphen Elixir (clear purple/red liquid, cinnamon/anise flavor) contains 12.5 mg diphenhydramine hydrochloride with 14% alcohol and is supplied in the following oral dosage forms: NDC 69067-092-04:    118 mL bottle
Authorization status:
Abbreviated New Drug Application
Authorization number:
69067-092-04

DIPHEN- diphenhydramine hydrochloride solution

Foxland Pharmaceuticals, Inc.

----------

Diphen Elixir

Rx ONLY

DESCRIPTION

Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2-

(diphenylmethoxy)-N,N -dimethylethylamine hydrochloride and has the molecular formula

H NO·HCl (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:

C H NO·HCl 291.82

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:

Antihis taminic

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

17

21

For active and prophylactic treatment of motion sickness.

Antiparkins onis m

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.

Nighttime Sleep-aid.

CONTRAINDICATIONS

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.

PRECAUTIONS

General

Diphen Elixir 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 Diphen Elixir 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

Diphen Elixir 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

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

Diphen Elixir should not be used in neonates and premature infants (see CONTRAINDICATIONS).

Diphen Elixir 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.

1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills,

dryness of the mouth, nose and throat.

2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.

3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion,

restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred

vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions.

5. GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.

6. GU System: Urinary frequency, difficult urination, urinary retention, early menses.

7. Respiratory System: Thickening of bronchial secretions, tightness of chest or throat and wheezing,

nasal stuffiness.

To report SUSPECTED ADVERSE REACTIONS, contact Foxland Pharmaceuticals, Inc. at 1-

844-430-7499 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 Diphen Elixir is quickly absorbed with maximum activity occurring in

approximately one hour. The duration of activity following an average dose of Diphen Elixir is from

four to six hours.

Always use a calibrated measuring device when administering Diphen Elixir to ensure the dose is

measured and administered accurately.

Adults

Take 10 mL - 20 mL (25mg-50mg) three or four times daily. The nighttime sleep-aid dosage is 20 mL

(50mg) at bedtime. Maximum daily dosage not to exceed 120 mL (300mg).

Pediatric Patients (over 20 lbs.)

Take 5 mL to 10 mL (12.5mg-25mg) three to four times daily. Maximum daily dosage not to exceed 120

mL (300mg). 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/m2/24 hours.

Data are not available on the use of Diphen Elixir 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

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from

freezing and light.

HOW SUPPLIED

Each 5mL of Diphen Elixir (clear purple/red liquid, cinnamon/anise flavor) contains 12.5 mg

diphenhydramine hydrochloride with 14% alcohol and is supplied in the following oral dosage forms:

NDC 69067-092-04: 118 mL bottle

Manufactured for:

Foxland Pharmaceuticals, Inc.

Trussville, AL 35173

FL-092-01

Rev. 04/2019

X048904C0419

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 69067-092-04

DIPHEN

ELIXIR

12.5 mg/5 mL

Each 5 mL (teaspoonful) contains:

Diphenhydramine HCl

12.5 mg

Alcohol

Rx Only

118 mL

Foxland

PHARMACEUTICALS, INC.

DIPHEN

diphenhydramine hydrochloride solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 9 0 6 7-0 9 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE

- UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

12.5 mg

in 5 mL

Foxland Pharmaceuticals, Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Citric Acid Mo no hydra te (UNII: 29 6 8 PHW8 QP)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C Red No . 4 0 (UNII: WZB9 127XOA)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

PINK

S core

S hap e

S iz e

Flavor

CINNAMON

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 6 7-0 9 2-0 4

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /11/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 8 7513

0 9 /11/20 19

Labeler -

Foxland Pharmaceuticals, Inc. (079407828)

Revised: 9/2019

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