A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Benadryl Indications, Dosage, Storage, Stability - Diphenhydramine (oral)
Benadryl Indications, Dosage, Storage, Stability - Diphenhydramine (oral)
INDICATIONS
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.
Nighttime sleep-aid.
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 to four
times daily. The nighttime sleep-aid dosage is 50 mg
at bedtime.
CHILDREN (over 20 lb)
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/m2/24 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.
HOW SUPPLIED
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP are supplied
as follows:
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg, Pink/Clear capsules,
Imprinted MUTUAL 103.
- Bottles of 100, NDC 53489-113-01
- Bottles of 1000, NDC 53489-113-10
DIPHENHYDRAMINE HYDROCHLORIDE 50 mg, Pink/Pink capsules,
Imprinted MUTUAL 107.
- Bottles of 100, NDC 53489-114-01
- Bottles of 1000, NDC 53489-114-10
Store at controlled room
temperature 15°-30°
C (59°-86° F).
Rx only
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