United States - English - NLM (National Library of Medicine)
DIPHEN- diphenhydramine hydrochloride solution
Foxland Pharmaceuticals, Inc.
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.
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:
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.
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.
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
Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma,
stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck
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.
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.
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
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to determine mutagenic and carcinogenic potential have not been
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.
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.
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,
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.
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.
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
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from
freezing and light.
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
Foxland Pharmaceuticals, Inc.
Trussville, AL 35173
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
12.5 mg/5 mL
Each 5 mL (teaspoonful) contains:
diphenhydramine hydrochloride solution
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:6 9 0 6 7-0 9 2
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE
- UNII:8 GTS8 2S8 3M)
in 5 mL
Foxland Pharmaceuticals, Inc.
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)
S hap e
S iz e
Marketing Start Date
Marketing End Date
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
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 8 7513
0 9 /11/20 19
Foxland Pharmaceuticals, Inc. (079407828)