DURADRYL
-
phenylephrine hydrochloride,
chlorpheniramine maleate and
methscopolamine nitrate syrup
Breckenridge Pharmaceutical, Inc.
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Duradryl®Syrup
- Alcohol Free
- Sugar Free
Each 5 mL (One teaspoonful) contains:
| Phenylephrine HCl | 10 mg |
| Chlorpheniramine Maleate | 2 mg |
| Methscopolamine Nitrate | 1.25 mg |
INACTIVE INGREDIENTS
Citric Acid, Sodium Benzoate, Glycerin, Cherry Flavor, Sorbitol, FD&C Red #40 and Purified Water.
Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Chlorpheniramine maleate is 2-[ρ-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate.
Phenylephrine HCl, is Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride.
Methscopolamine Nitrate is 3-Oxa-9-azoniatricyclo [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate, [7(S)-1α2β,4β,5α,7β]
CLINICAL PHARMACOLOGY
Chlorpheniramine maleate, an antihistamine, is an alkylamine antihistamine which possesses anticholinergic and sedative effects. Phenylephrine HCl, a decongestant is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors, with a mild central stimulant effect. Methscopolamine nitrate an anticholinergic, is a derivative of scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its inability to cross the blood-brain barrier.
INDICATIONS AND USAGE
Relief of respiratory congestion, allergic rhinitis, and vasomotor rhinitis.
CONTRAINDICATIONS
Contraindicated in patients receiving MAO inhibitors (or for 14 days after stopping MAOI therapy), in patients with a known hypersensitivity to any of the ingredients, and in patients with glaucoma, hypertension, cardiac disease, or hyperthyroidism.
WARNINGS
Sympathomimetic amines should be used cautiously in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions.
Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).
PRECAUTIONS
General
Use cautiously, if at all, in the presence of pyloric obstruction. Use with caution in those over 40 years of age, in the presence of diabetes mellitus or urinary retention, and in men with prostatic hypertrophy or a history of bladder difficulty. If disturbances in urination occur, medication should be discontinued for 1 or 2 days and then resumed at lower dosage. Antihistamines may cause excitability, especially in children. Information for patients: Because this product may cause blurring of vision or drowsiness, patients should be cautioned against driving or operating machinery.
Drug interactions
MAO inhibitors (or for 14 days after stopping MAOI therapy), and beta-adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol or other CNS depressants may have an additive effect.
Pregnancy Category C
It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.
Nursing mothers
It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Co-administration of Duradryl® Syrup and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and Duradryl® Syrup is not recommended.
Pediatric use
Safety and effectiveness in the pediatric population, under 6, have not been established.
Geriatric use
Anticholinergic and CNS stimulant effects are more likely to occur in older patients; danger of precipitating undiagnosed glaucoma; possible impairment of memory.
ADVERSE REACTIONS
Side effects include xerostomia, blurred vision, bradycardia, mydriasis, flushing, palpitation, dizziness, constipation, urinary retention, drowsiness, increased irritability or excitability, nausea or dysphagia.
OVERDOSAGE
The treatment of overdose is essentially symptomatic and supportive. The stomach should be emptied promptly by lavage or by induction of emesis (syrup of ipecac recommended). The installation of activated charcoal into the stomach also should be considered. 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.
DOSAGE AND ADMINISTRATION
Adults and children 12 years of age and older
1 or 2 teaspoonfuls every 3 or 4 hours.
Children 6 to under 12 years of age
½ to 1 teaspoonful depending on age and body weight, may be repeated every 4 hours. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)
HOW SUPPLIED
Duradryl® is supplied as a red, cherry flavored syrup in 16 oz bottles, NDC 51991-016-16.
Store at 25°C (77°F); excursions permitted to 15-30°C (59°-86°F). See USP Controlled Room Temperature. Store in tight-light resistant containers. Keep from freezing.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Iss. 11-04 Rev. 4/08
Rx Only
Mfg by: Tri-Med Laboratories, Inc.
Somerset, NJ 08873
Dist by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Breckenridge
Pharmaceutical, Inc.
NDC 51991-016-16
Duradryl®
Syrup
- Alcohol Free
- Sugar Free
Each 5 mL (One teaspoonful)
contains:
Phenylephrine HCl 10 mg
Chlorpheniramine Maleate 2 mg
Methscopolamine
Nitrate 1.25 mg
INACTIVE INGREDIENTS: Citric
Acid, Sodium Benzoate, Glycerin,
Cherry Flavor, Sorbitol, FD&C Red
#40 and Purified Water.
Keep this and all drugs out of the reach of children.
In case of accidental overdose, seek professional
assistance or contact a Poison Control
Center immediately.
Rx Only
Mfg by: Tri-Med Laboratories, Inc.
Somerset, NJ 08873
Dist by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Net Contents:
16 fl oz (One Pint) 473 mL
| DURADRYL
phenylephrine hydrochloride, chlorpheniramine maleate, and 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 | 01/01/2001 | 09/30/2010 | |
| Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Trimed | 182050567 | MANUFACTURE | |