{"adverse_reactions":["Adverse Reactions: The most frequent adverse reactions are underscored. 1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat. 2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia and extrasystoles. 3. Hematologic System : Hemolytic anemia, thrombocytopenia and agranulocytosis. 4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions. 5. GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. 6. GU System: Urinary frequency, difficult urination, urinary retention, early menses. 7. Respiratory System : Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness. Serious side effects with oral antihistamines or sympathomimetics have been rare."],"clinical_pharmacology":["Clinical Pharmacology: DiphenMax D Tablets combine the antihistaminic action of diphenhydramine tannate, with the sympathomimetic decongestant effect of phenylephrine tannate. DiphenMax D Tablets have an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells."],"contraindications":["Contraindications: DiphenMax D Tablets are contraindicated for newborns, nursing mothers, and patients who are sensitive to any of the ingredients or related compounds."],"description":["Description: DiphenMax D is an antihistamine/decongestant combination available for oral administration as a chewable tablet. Each chewable tablet contains: Diphenhydramine Tannate ............ 25 mg Phenylephrine Tannate ................. 10 mg Other ingredients: Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Silica, Sodium Lauryl Sulfate, Sodium Saccharin, Stearic Acid, Sugar and Xylitol."],"dosage_and_administration":["Dosage & Administration: Administer the recommended dose every 12 hours. DiphenMax D Chewable Tablets: Adults and children 12 years of age and over - 1 to 2 tablets; Children 6 to under 12 years of age - 1⁄2 to 1 tablet; Children under six years of age - consult a physician."],"effective_time":"20091210","how_supplied":["How Supplied: DiphenMax D Chewable Tablets are beige speckled, oval-shaped tablets with grape flavor, debossed “RE 205” on one side and plain on the other side, containing in each chewable tablet: diphenhydramine tannate 25 mg and phenylephrine tannate 10 mg. Available in bottles of 60 tablets (NDC 68032-205-60). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Storage: Store at controlled room temperature, 15°-30°C (59°-86°F). Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Manufactured for: River's Edge Pharmaceuticals, LLC. Suwanee, GA 30024 Iss. 04/08 205-11"],"id":"651bbf83-f1c9-4cfd-80d0-cb9f44a00c2f","indications_and_usage":["Indications & Usage: DiphenMax D Tablets are indicated for the symptomatic relief of allergic reactions and nasal congestion associated with allergic and perennial rhinitis, sinusitis and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease."],"information_for_patients":["Information for Patients: Patients taking DiphenMax D Tablets should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc. Drug Interactions: DiphenMax D Tablets have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and the overall effects of sympathomimetics agents. Carcinogenesis, mutagenesis, impairment of fertility: Long term studies in animals to determine mutagenic and carcinogenic potential have not been performed. Pregnancy: Teratogenic effects: Category C. Animal reproduction studies have not been conducted with DiphenMax D Tablets. It is also not known whether DiphenMax D Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DiphenMax D Tablets should be given to a pregnant woman only if clearly needed. Nursing mothers: DiphenMax D Tablets should not be administered to a nursing woman."],"openfda":{},"overdosage":["Overdosage: Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent. Dry mouth; fixed, dilated pupils; flushing, and gastrointestinal symptoms may also occur. 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."],"package_label_principal_display_panel":["Package Label: DO NOT USE IF IMPRINTED SEAL UNDER THE CAP IS BROKEN OR MISSING Usual Dosage : Administer the recommended dose every 12 hours. Adults and children 12 years of age and over - 1 to 2 tablets; Children 6 to under 12 years of ag e - 1/2 to 1 tablet; Children under 6 years of ag e - consult a physician. See product literature for full prescribing information. Protect from moisture. Store at controlled room temperature, 15°-30°C (59°-86°F). Pharmacists: Dispense in a tight, light-resistant container as defined in USP/NF with a child-resistant closure. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: River's Edge Pharmaceuticals, LLC. Suwanee, GA 30024 Iss. 01/08 205-21 Lot/Exp. date: Insert1 Insert2 Label Barcode"],"precautions":["Precautions: General: Diphenhydramine has an atropine-like action and therefore, should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension. Use with caution in patients with lower respiratory disease including asthma. Antihistamines may cause excitation, particularly in children, but their combination with sympathomimetics may cause either mild stimulation or mild sedation."],"set_id":"2ff4bd27-ebed-48a2-849a-15dec7b0b590","spl_product_data_elements":["DiphenMax DiphenMax D DIPHENHYDRAMINE DIPHENHYDRAMINE PHENYLEPHRINE PHENYLEPHRINE beige speckled oval-shaped RE205"],"version":"5","warnings":["Warnings: Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma, or prostatic hypertrophy. Do not use in patients taking monoamine oxidase (MAO) inhibitors, or for 14 days after stopping treatment with an MAOI. Antihistamines should be used with considerable caution in patients with narrowangle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients."]}