Ryneze Liquid

This product is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its
ingredients. It is also contraindicated in women who are pregnant or nursing.

It is also contraindicated in newborn or premature infants, because this age group has an increased susceptibility to the
anticholinergic side effects of chlorpheniramine maleate. Geriatric patients may be more sensitive to the effects of this medication.

Risk-benefit should be considered when the following conditions exist: Acute asthma; Bladder neck obstruction;
Brain damage in children; Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease,
and mitral stenosis; Cardiovascular disease; Diabetes mellitus; Down’s Syndrome; Esophagitis, reflux; Narrow angle
glaucoma; Acute hemorrhage with unstable cardiovascular status; Hepatic function impairment; Hernia; Hypertension;
Hyperthyroidism; Intestinal atony in the elderly or debilitated patient; Chronic lung disease; Myasthenia gravis; Autonomic
neuropathy; Paralytic ileus; Prostatic hypertrophy; Psychiatric disorders; Pyloric obstruction; Renal function impairment;
Spastic paralysis, in children; Tachycardia; Toxemia of pregnancy; Ulcerative colitis; Urinary retention, or
predisposition to; Uropathy; Xerostomia.

The following may be especially important in patient monitoring (other tests may be
warranted in some patients, depending on conditions): Blood pressure determination – recommended at
frequent intervals during therapy: Electrocardiogram (ECG) – monitoring may be required: Intraocular
pressure determination – recommended at periodic intervals, as these medications may increase the
intraocular pressure.

Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation,
drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects,
such as constipation, dryness of the mouth, and urinary retention (especially in males). If these side effects occur
and continue or are severe, medication should probably be discontinued.

Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of
precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, with the
continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for
many functions of the brain, including memory function.

The following adverse reactions have been observed with the use of chlorpheniramine and
scopolamine methyl nitrate; Arrhytmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness,
dryness of mouth, hallucinations, hypotension, hypertension, increased sweating, loss of appetite,
paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or
feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting.

Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose and
throat are more likely to occur in the elderly. Nightmares, unusual excitement, nervousness,
restlessness, or irritability are more likely to occur in children and the elderly. When anticholinergics are given
to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in
body temperature.

In all cases of suspected overdose, immediately call your regional poison center and/or
contact a physician immediately. The stomach should be emptied promptly by lavage or induction of emesis with
syrup of ipecac. The installation of activated charcoal into he stomach also should be considered. The treatment of
overdose is essentially sypmptomatic and supportive. If respiratory depression is present treat promptly with oxygen and/or
mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type
drugs should be used.

RYNEZE® LIQUID is supplied as a clear, grape-flavored liquid, dye free, sugar free, alcohol
free, and gluten free in 16 fl oz (473 mL) bottles, NDC 24839-346-16, and 10 mL sample,
NDC 24839-346-10

Pharmacist: Store at controlled room temperature, 15°-30°C (59°-86°F). Avoid exposure to heat. Dispense
in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.