A-TAN 12X SUSPENSION
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phenylephrine tannate,
pyrilamine tannate and
guaifenesin suspension
Amneal Pharmaceuticals
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A-Tan 12XRx Only
DESCRIPTION
A-Tan 12X is an antihistamine/nasal decongestant/expectorant available for oral administration as a Suspension.
Each 5 mL (one teaspoonful) of the blue-colored, grape flavored suspension contains:
Phenylephrine Tannate . . . . . . . . . . 5 mg
Pyrilamine Tannate . . . . . . . . . 30 mg
Guaifenesin . . . . . . 100 mg
Other ingredients: citric acid, FD&C Blue #1, FD&C Red No. 40, flavor, propylene glycol, glycerin, methylparaben, sodium benzoate, sodium saccharin, xanthan gum and purified water.
CLINICAL PHARMACOLOGY
Phenylephrine is a sympathomimetic nasal decongestant which acts predominantly on alpha adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction with minimal action on beta receptors. It functions as an oral nasal decongestant with minimal central nervous system (CNS) stimulation and it promotes sinus drainage. Pyrilamine provides antihistaminic action. Guaifenesin is an expectorant which increases the output of phlegm (sputum) and bronchial secretions by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and changes a dry, unproductive cough to one that is more productive and less frequent.
INDICATIONS AND USAGE
This product is indicated for the temporary, symptomatic relief of the coryza, nasal congestion and dry nonproductive cough associated with the common cold, sinusitis, and other respiratory allergies. Appropriate therapy should be provided for the primary disease. Helps drainage of the bronchial tubes by thinning the mucus.
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of its ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease, and patients on monoamine oxidase (MAO) inhibitor therapy.
WARNINGS
This product should be prescribed with caution in patients with persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or where cough is accompanied by excessive secretions. Advise patients to take medication a few hours before bedtime to minimize the possibility of sleeplessness. The medication should be taken with a glass of water after each dose, to help loosen mucus in the lungs. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes mellitus, narrow angle glaucoma or prostatic hypertrophy.
PRECAUTIONS
General: Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Antihistamines may cause excitation, particularly in children, but their combination with sympathomimetics may cause either mild stimulation or mild sedation.
Information for patients: Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this product. Patients should be warned not to use these products if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product.
Drug Interactions: MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents.
Carcinogenesis, mutagenesis, impairment of fertility: No long term animal studies have been performed with this product.
Pregnancy:Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with this product. 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: This product should not be administered to a nursing woman.
Geriatrics: Phenylephrine should be used with caution in the elderly because they may be more sensitive to the effects of sympathomimetics.
Laboratory test interactions: Guaifenesin or its metabolites may cause color interference with the VMA (vanillylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.
ADVERSE REACTIONS
Adverse effects associated with phenylephrine may include nervousness, restlessness, and headache. Adverse effects associated with antihistamines may include drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare. Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly.
Dizziness, headache, and rash (including urticaria) have been reported rarely.
OVERDOSAGE
Signs & symptoms: May vary from CNS depression to stimulation (restlessness to convulsions).
Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent.
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. The acute toxicity of guaifenesin is low and overdosage is unlikely to produce serious toxic effects. In laboratory animals, no toxicity resulted when guaifenesin was administered by stomach tube in doses up to 5 grams/kg.
DOSAGE AND ADMINISTRATION
Administer the recommended dose every 12 hours.
Children over six years of age: 5 to 10 mL. (1 to 2 teaspoonfuls);
Children two to six years of age: 2.5 to 5 mL (1/2 to 1 teaspoonful);
Children under two years of age: Titrate dose individually.
HOW SUPPLIED
A-Tan 12X Suspension, each teaspoonful (5 mL) of which contains phenylephrine tannate 5mg, pyrilmine tannate 30 mg and guaifenesin 100 mg is supplied as a blue colored, grape flavored homogeneous suspension. A-Tan 12X Suspension is available in bottles of 4 fI oz (118 ml) NDC 65162-530-86.
Storage: Store at Controlled Room Temperature 15°-30°C (59°-86°F). Protect from freezing.
Dispense in a tight, light-resistant container with a child-resistant closure as directed in the USP/NF.
SHAKE WELL BEFORE USE.
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.
Distributed by:
Akyma Pharmaceuticals LLC
Glasgow, KY 42141
Manufactured by:
Deltex Pharmaceuticals, Inc.
Rosenberg, TX 77471
MF# 277 Rev. 01/06
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
| A-TAN 12X SUSPENSION
phenylephire tannate, pyralamine tannate and guaifenesin suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 01/06/2006 | 12/05/2008 | |
| Labeler - Amneal Pharmaceuticals (123797875) |
| Registrant - Amneal Pharmaceuticals (123797875) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Amneal Pharmaceuticals | 963900878 | ANALYSIS, LABEL, MANUFACTURE, PACK | |