Generic Name: triprolidine hydrochloride
Dosage Form: oral liquid
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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Tripohist™ Liquid is an alcohol free, sugar free red syrup for oral administration having an apple odor and flavor.
Each teaspoonful (5 mL) contains:
|Triprolidine Hydrochloride||1.25 mg|
Sodium Benzoate, Citric Acid, Saccharin Sodium, Glycerin, Sorbitol Solution, Apple Flavor, FD&C Red No. 40 and Purified Water.
Triprolidine Hydrochloride is an antihistamine, chemically it is: Pyridine, 2-[1-(4-methyl-phenyl)-3-(1-pyrrolidinyl)-1-propenyl]-, monohydrochloride, monohydrate, (E)-. It's structure is as follows:
C19H22N2•HCl•H2O M.W. 332.87
Tripohist - Clinical Pharmacology
Triprolidine provides symptomatic relief of conditions believed to depend wholly or partly upon the release of histamine. Triprolidine hydrochloride antagonizes the effects of histamine by competing for histamine-1 (H1) receptor sites. The serum half-life for triprolidine is 3 to 3.3 hours.
Indications and Usage for Tripohist
Triprolidine provides symptomatic relief of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, and mild uncomplicated allergic skin manifestations of urticaria and angioedema.
Tripohist™ Liquid is contraindicated in individuals who have a known hypersensitivity to triprolidine HCl or any of its ingredients.
Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a physician. If symptoms do not improve within 7 days or are accompanied by a fever, consult a physician. Do not take this product, unless directed by a physician, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery.
Antihistamines should be used with considerable caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction.
This product may cause excitability especially in children.
Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's physician.
This product may cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's physician.
MAO inhibitors (or for 14 days after stopping MAOI therapy) and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines. Concomitant use of antihistamines with tricyclic antidepressants, barbiturates, and other CNS depressants may have an additive effect. Antihistamines should be used with considerable caution in patients with history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No adequate or well controlled studies have been conducted to determine whether the components of Tripohist™ Liquid have a potential for carcinogenesis, mutagenesis, or impairment of fertility.
PregnancyPregnancy Category C
Animal reproduction studies have not been conducted with this product. It is not known whether it can cause fetal harm when administered to a pregnant women or can effect reproduction capacity. This product should not be administered to pregnant women.
Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.
Safety and effectiveness in the pediatric population, under 6, have not been established.
Possible side effects of antihistamines are drowsiness, dry mouth, anorexia, nausea, vomiting, headache, dizziness, nervousness, blurred vision, polyuria, heartburn, dysuria, urinary retention and very rarely, dermatitis.
Signs and Symptoms
Manifestations of antihistamine overdosage may vary from CNS depression (sedation, apnea, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors or convulsions). Other signs and symptoms may be dizziness, tinnitus, blurred vision and hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms.
Treatment of the signs and symptoms of overdosage is symptomatic and supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water.
Tripohist Dosage and Administration
2 Teaspoonfuls every 4 to 6 hours not to exceed 4 doses in a 24 hour period.
Children 6 to 12
1 Teaspoonful every 4 to 6 hours not to exceed 4 doses in a 24 hour period.
This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)
How is Tripohist Supplied
Tripohist™ Liquid is supplied as a sugar free, alcohol free, red, apple flavored liquid in bottles of 16 fl.oz. (One Pint), NDC 51991-531-16.
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.
Store at 25°C(77°F); excursions permitted to 15°-30°C(59°-86°F). See USP Controlled Room Temperature. Protect from freezing.
Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Tri-Med Laboratories, Inc.
Somerset, NJ 08873
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
- Sugar Free
- Alcohol Free
Description: Each 5 mL (one teaspoonful) for oral
Triprolidine Hydrochloride 1.25 mg
INACTIVE INGREDIENTS: Sodium Benzoate,
Citric Acid, Saccharin Sodium, Glycerin, Sorbitol
Solution, Apple Flavor, FD&C Red No. 40, Purified
16 fl. oz. (One Pint) 473 mL
triprolidine hydrochloride liquid
|Labeler - Breckenridge Pharmaceutical, Inc. (150554335)|
|TriMed Laboratories, Inc.||182050567||MANUFACTURE|
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- Drug class: antihistamines