DALLERGY PE SYRUP
-
phenylephrine hydrochloride,
chlorpheniramine maleate and
methscopolamine nitrate syrup
Laser Pharmaceuticals LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Rx Only
DESCRIPTION:
Each 5 mL (1 teaspoonful) of DALLERGY PE SYRUP contains:
Phenylephrine Hydrochloride.................. 10 mg
Chlorpheniramine Maleate..................... 2 mg
Methscopolamine Nitrate.....................0.75 mg
Phenylephrine hydrochloride is a decongestant having the chemical name Benzenemethanol,
3-hydroxy-α-[(methylamino) methyl]-, hydrochloride.
Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine,
γ-(4 chlorophenyl)-N, N-dimethyl-, (Z) -2-butenedioate (1:1).
Methscopolamine nitrate is an anticholinergic having the chemical name 3-Oxa-9-azoniatricyclo,
[3.3.1.0] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate,
[7(S)-(1α, 2β, 4β, 5α, 7β)]-.
Citric acid, FD and C Red #40, FD and C Blue No. 1, glycerin, grape flavoring, maltitol, propylene
glycol, purified water, sodium saccharin, and sorbitol.
DALLERGY® PE SYRUP contains ingredients of the following therapeutic classes: nasal
decongestant, antihistamine, and antisecretory agent.
Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and
has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal
CNS stimulation.
Chlorpheniramine maleate is an alkylamine type antihistamine. This group of antihistamines is among
the most active histamine antagonists and is generally effective in relatively low doses. The drugs are
not so prone to produce drowsiness and are among the most suitable agents for daytime use; but
again, a significant proportion of patients do experience this effect.
Methscopolamine nitrate is a quaternary ammonium derivative of scopolamine, which possesses the
peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its
lack of ability to cross the blood-brain barrier. In this formulation, it is used because of its antisecretory
effects on the respiratory system.
For the relief of upper respiratory symptoms associated with allergies and the common cold, such as:
nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever.
Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension,
severe coronary artery disease, patients on MAO inhibitor therapy, patients with narrow angle
glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack.
Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic
heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly
(60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability,
especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or
sleeplessness may occur.
General:
Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid
disease. The antihistamine in this product may exhibit additive effects with other CNS depressants,
including alcohol.
Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor
vehicles should be cautioned accordingly.
MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics.
Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine,
reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other
CNS depressants may have an additive effect.
It is not known whether DALLERGY® PE SYRUP can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity. DALLERGY® PE SYRUP should be given
to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted
in human milk, caution should be exercised when DALLERGY® PE SYRUP is administered to a
nursing woman.
Safety and effectiveness of DALLERGY® PE SYRUP in children below the age of 6 have not been established.
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision,
cardiac palpitations, flushing, increased irritability or excitement (especially in children).
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 by induction of
emesis with syrup of ipecac. The installation of activated charcoal into the stomach also should be
considered. The treatment of overdose is essentially symptomatic 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.
Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL) every 4 to 6 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 4 to 6 hours.
Children under 6 years of age:
Consult a physician.
Not to exceed 4 doses in 24 hours.
16 fl oz (473 mL) (NDC 16477-821-01) and 1 fl oz (30 mL) (NDC 16477-821-30) bottles of purple
colored, grape flavored syrup.
Store at controlled room temperature 20o-25oC (68o-77oF). [See USP].
Tamper-evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
Rx Only
R06/09
DALLERGY
PE SYRUP
phenylephrine hydrochloride, chlorpheniramine maleate, methscopolamine nitrate syrup |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved drug other | 04/30/2009 | 08/30/2011 |
Labeler - Laser Pharmaceuticals LLC (614417132) |
Registrant - Great Southern Laboratories (056139553) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Great Southern Laboratories | 056139553 | manufacture |
Revised: 11/2011 Laser Pharmaceuticals LLC