DALLERGY
-
chlorpheniramine maleate,
phenylephrine hydrochloride and
methscopolamine nitrate syrup
Laser Pharmaceuticals LLC
----------
Dallergy SyrupDALLERGY SYRUP
DESCRIPTION:Each 5 mL (1 teaspoonful) contains:
Chlorpheniramine Maleate............... 2 mg
Phenylephrine Hydrochloride........... 8 mg
Methscopolamine Nitrate............. 0.75 mg
Chlorpheniramine Maleate is an antihistamine having the chemical name 2-pyridinepropanamine, γ-(4 chlorophenyl)-N,
N-dimethyl-, (Z) -2- butenedioate (1:1).
Phenylephrine HCl is a decongestant having the chemical name Benzenemethanol, 3-hydroxy-α-[(methylamino)
methyl]-, hydrochloride.
Methscopolamine 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)]-.
DALLERGY® SYRUP contains ingredients of the following therapeutic classes: nasal decongestant, antihistamine, and
antisecretory agent.
CLINICAL PHARMACOLOGY:
Chlorpheniramine Maleate is an alkylamine type antihistamine. This group of antihistamines is among the mostactive 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.
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.
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.
INDICATIONS AND USAGE:
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.
CONTRAINDICATIONS:
Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension, severecoronary artery disease, patients on MAO inhibitor therapy, patients with narrow angle glaucoma, urinary
retention, peptic ulcer, and during an asthmatic attack.
WARNINGS:
Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heartdisease, 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.
PRECAUTIONS:
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.
Information for Patients:
Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehiclesshould be cautioned accordingly.
Drug Interactions:
MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimeticsmay 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.
Pregnancy: Pregnancy Category C:
It is not known whether DALLERGY® can cause fetal harm when administered to a pregnant woman or caneffect reproduction capacity. DALLERGY® should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in humanmilk, caution should be exercised when DALLERGY® is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness of DALLERGY® in children below the age of 6 have not been established.ADVERSE REACTIONS:
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiacpalpitations, flushing, increased irritability or excitement (especially in children).
OVERDOSAGE AND TREATMENT OF OVERDOSAGE:
In all cases of suspected overdose, immediately call your regional poison center, and/or contact a physicianimmediately. 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). Children 6 to under 12
years of age: 1 teaspoonful (5 mL). May be repeated in 4 to 6 hours if required for relief. Not to exceed
4 doses in 24 hours. Children under 6: at discretion of physician.
HOW SUPPLIED:
16 fl oz (473 mL) (NDC 16477-819-01) bottles and 1 oz (30 mL) (NDC 16477-819-30) samples of purple colored syrup.Store at controlled room temperature 15o-30oC (59o-86oF).
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 Labs
Houston, TX 77099
Laser
2770802
Rev. 09/09
PRODUCT PACKAGING:
The packaging below represents the labeling currently used:Principal Display and Side Panel for 473 mL Label:
NDC: 16477-819-01
Dallergy
SYRUP
New Improved Formula
Rx
Nasal Decongestant
Antihistamine
Antisecretory
Each 5 mL (1 teaspoonful) contains:
Chlorpheniramine Maleate.......... 2 mg
Phenylephrine Hydrochloride...... 8 mg
Methscopolamine Nitrate........ 0.75 mg
LASER
Rx Only
16 fl oz (473 mL)
USUAL DOSAGE:
Adults and children 12 years and older: 2 teaspoonfuls (10 mL)
Children 6 to under 12 years of age: 1 teaspoonful (5 mL)
May be repeated in 4 to 6 hours if required for relief. Not to exceed 4 doses in 24 hours.
Children under 6: at discretion of physician.
For full prescribing information see attached insert.
Store at controlled room temperature 15o-30oC (59o-86oF).
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 USF/NF with a child-resistant closure.
WARNING: Keep this and all drugs out of reach of children.
LASER
Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
Rev. 09/09
| DALLERGY
chlorpheniramine maleate, phenylephrine hydrochloride, methscopolamine nitrate syrup |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 02/06/2006 | ||
| Labeler - Laser Pharmaceuticals LLC (614417132) |
| Registrant - Great Southern Laboratories (056139553) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Great Southern Laboratories | 056139553 | manufacture | |