HISTEX-DM DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE ALLEGIS PHARMACEUTICALS, LLC FDA Approved Uses temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages
FunFoxMeds bottle
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr 20 mg Cough Suppressant Phenylephrine HCl 10 mg Decongestant Triprolidine HCl 2.5 mg Antihistamine
Inactive Ingredients
Inactive ingredients Citric Acid Glycerin Propylene Glycol Purified Water Sodium Citrate Sodium Saccharin Sorbitol Grape Flavor.
Strengths
5 ml 20 mg 10 mg 2.5 mg
Quantities
473 ml 5 ml
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Common Cold Hay Fever Allergic Rhinitis Or Other Upper Respiratory Allergies Cough Due To Minor Throat Or Bronchial Irritation Runny Nose Sneezing Itching Of The Nose Or Throat Itchy Watery Eyes Nasal Congestion Reduces Swelling Of Nasal Passages

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0328595804163
UNII
9D2RTI9KYH 04JA59TNSJ YAN7R5L890
Packaging

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 28595-804-16 Antihistamine • Decongestant Cough Suppressant HISTEX™-DM Syrup Each teaspoonful (5 mL) contains: Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg Triprolidine HCl 2.5 mg Sugar-Free • Dye Free Alcohol Free Grape Flavor 16 fl oz (473 mL) Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 28595-804-16 Antihistamine • Decongestant Cough Suppressant HISTEX™-DM Syrup Each teaspoonful (5 mL) contains: Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg Triprolidine HCl 2.5 mg Sugar-Free • Dye Free Alcohol Free Grape Flavor 16 fl oz (473 mL) Label

Overview

Uses temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Indications & Usage

Uses temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage & Administration

Directions Do not exceed recommended dosage. AGE DOSE Adults and Children 12 years of age and older: 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor Children 6 to under 12 years of age ½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor. Children under 6 years of age Consult a doctor

Warnings & Precautions
Warnings Do not exceed recommended dosage. Do not use this product If you 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 you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure thyroid disease diabetes glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr 20 mg Cough Suppressant Phenylephrine HCl 10 mg Decongestant Triprolidine HCl 2.5 mg Antihistamine

Do Not Use

Do not use this product If you 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 you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

When Using

When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur

Keep Out of Reach of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other Information Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken. Dispense in a tight, light-resistant container with a child-resistant cap.

Questions

Questions? Comments? Call 1-866-633-9033.


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