DIPHENMAX
-
diphenhydramine and
phenylephrine tablet, chewable
River's Edge Pharmaceuticals, LLC
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DiphenMax D Chewable Tablets (Diphenhydramine Tannate and Phenylephrine Tannate) Rx OnlyDescription:
DiphenMax D is an antihistamine/decongestant
combination available for oral
administration as a chewable tablet.
Each chewable tablet contains:
Diphenhydramine Tannate ............ 25 mg
Phenylephrine Tannate ................. 10 mg
Other ingredients: Croscarmellose Sodium,
Grape Flavor, Magnesium Stearate,
Microcrystalline Cellulose, Silica, Sodium
Lauryl Sulfate, Sodium Saccharin, Stearic
Acid, Sugar and Xylitol.
Clinical Pharmacology:
DiphenMax D Tablets combine the antihistaminic
action of diphenhydramine tannate,
with the sympathomimetic decongestant
effect of phenylephrine tannate.
DiphenMax D Tablets have an antihistamine
with anticholinergic (drying) and
sedative side effects. Antihistamines
appear to compete with histamine for cell
receptor sites on effector cells.
Indications & Usage:
DiphenMax D Tablets are indicated for
the symptomatic relief of allergic reactions
and nasal congestion associated
with allergic and perennial rhinitis, sinusitis
and other upper respiratory tract conditions.
Appropriate therapy should be
provided for the primary disease.
Contraindications:
DiphenMax D Tablets are contraindicated
for newborns, nursing mothers, and
patients who are sensitive to any of the
ingredients or related compounds.
Warnings:
Use with caution in patients with hypertension,
cardiovascular disease, hyperthyroidism,
diabetes, narrow angle glaucoma,
or prostatic hypertrophy. Do not
use in patients taking monoamine oxidase
(MAO) inhibitors, or for 14 days
after stopping treatment with an MAOI.
Antihistamines should be used with considerable
caution in patients with narrowangle
glaucoma, stenosing peptic ulcer,
pyloroduodenal obstruction, symptomatic
prostatic hypertrophy, or bladder-neck
obstruction. Antihistamines are more likely
to cause dizziness, sedation and
hypotension in elderly patients.
Precautions:
General: Diphenhydramine 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.
Antihistamines may cause excitation, particularly
in children, but their combination
with sympathomimetics may cause either
mild stimulation or mild sedation.
Information for Patients:
Patients taking
DiphenMax D Tablets 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: DiphenMax D Tablets
have additive effects with alcohol and
other CNS depressants (hypnotics, sedatives,
tranquilizers, etc.). MAO inhibitors
prolong and intensify the anticholinergic
(drying) effects of antihistamines and the
overall effects of sympathomimetics
agents.
Carcinogenesis, mutagenesis, impairment
of fertility:Long term studies in
animals to determine mutagenic and
carcinogenic potential have not been
performed.
Pregnancy: Teratogenic effects:
Category C. Animal reproduction studies
have not been conducted with
DiphenMax D Tablets. It is also not
known whether DiphenMax D Tablets
can cause fetal harm when administered
to a pregnant woman or can affect reproduction
capacity. DiphenMax D Tablets
should be given to a pregnant woman
only if clearly needed.
Nursing mothers: DiphenMax D Tablets
should not be administered to a nursing
woman.
Adverse Reactions:
The most frequent adverse reactions are
underscored.
1. General: Urticaria, drug rash, anaphylactic
shock, photosensitivity, excessive
perspiration, chills, dryness of mouth,
nose, and throat.
2. Cardiovascular System: Hypotension,
headache, palpitations, tachycardia and
extrasystoles.
3. Hematologic System: Hemolytic anemia,
thrombocytopenia and 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.
Serious side effects with oral antihistamines
or sympathomimetics have been
rare.
Overdosage:
Antihistamine overdosage reactions may
vary from central nervous system depression
to stimulation. Stimulation is particularly
likely in pediatric patients.
Antihistamine overdosage in young children
may lead to convulsions and death.
Atropine-like signs and symptoms may be
prominent. Dry mouth; fixed, dilated
pupils; flushing, and gastrointestinal
symptoms may also occur.
Treatment: Induce vomiting if it has not
occurred spontaneously. Precautions
must be taken against aspiration especially
in infants, children and comatose
patients. If gastric lavage is indicated, isotonic
or half-isotonic saline solution is preferred.
Stimulants should not be used. If
hypotension is a problem, vasopressor
agents may be considered.
Dosage & Administration:
Administer the recommended dose every
12 hours.
DiphenMax D Chewable Tablets:
Adults and children 12 years of age
and over - 1 to 2 tablets; Children 6 to
under 12 years of age - 1⁄2 to 1 tablet;
Children under six years of age - consult
a physician.
How Supplied:
DiphenMax D Chewable Tablets are beige
speckled, oval-shaped tablets with grape
flavor, debossed “RE 205” on one side
and plain on the other side, containing in
each chewable tablet: diphenhydramine
tannate 25 mg and phenylephrine tannate
10 mg. Available in bottles of 60 tablets
(NDC 68032-205-60).
Protect from moisture.
Dispense in a tight, light-resistant container
as defined in the USP/NF with a
child-resistant closure.
Storage: Store at controlled room temperature,
15°-30°C (59°-86°F).
Warning: Keep this and all medications
out of the reach of children. In
case of accidental overdose, seek
professional assistance or contact a
poison control center immediately.
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Iss. 04/08 205-11
Package Label:
DO NOT USE IF IMPRINTED SEAL UNDER
THE CAP IS BROKEN OR MISSING
Usual Dosage: Administer the recommended
dose every 12 hours. Adults and children 12
years of age and over - 1 to 2 tablets;
Children 6 to under 12 years of age - 1/2 to 1
tablet; Children under 6 years of age -
consult a physician.
See product literature for full prescribing
information.
Protect from moisture.
Store at controlled room temperature,
15°-30°C (59°-86°F).
Pharmacists: Dispense in a tight,
light-resistant container as defined in USP/NF
with a child-resistant closure.
KEEP THIS AND ALL MEDICATIONS OUT OF
THE REACH OF CHILDREN.
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024 Iss. 01/08 205-21
Lot/Exp. date:
| DIPHENMAX
diphenmax d tablet, chewable |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/01/2008 | 11/09/2009 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |