DIPHENHYDRAMINE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Pharmaceutical Associates, Inc.

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL

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 h

Product summary:

Each 5 mL of Diphenhydramine Hydrochloride Oral Solution USP (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: 0121-0489-04: 118 mL (4 oz) bottle NDC 0121-0489-05:  5 mL unit dose cup NDC 0121-0489-00:  Case contains 100 unit dose cups of 5 mL (0121-0489-05) packaged in 10  trays of 10 unit dose cups each. NDC 0121-0978-10:  10 mL unit dose cup NDC 0121-0978-00:  Case contains 100 unit dose cups of 10 mL (0121-0978-10) packaged in 10  trays of 10 unit dose cups each. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE
HYDROCHLORIDE SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
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DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION USP
RX ONLY
DESCRIPTION
Diphenhydramine hydrochloride is an antihistamine drug having the
chemical name 2-
(diphenylmethoxy)-N,N -dimethylethylamine hydrochloride and has the
molecular
formula C
H
NO•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
17
21
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 parkinson