Tusnel DM Pediatric

Tusnel DM Pediatric DEXTROMETHORPHAN GUIAFENESIN PSEUDOEPHEDRINE HCL LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION FDA Approved Other information store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature] Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering Oral dosing device enclosed

Generic: DEXTROMETHORPHAN GUIAFENESIN PSEUDOEPHEDRINE HCL

Mfr: LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION FDA OTC

Substance Dextromethorphan Hydrobromide

Route

ORAL

Applications

M012

Product NDC

54859-0603-00 54859-0603-02

Package NDC

54859-603-02

Drug Facts

Composition & Profile

Active Ingredients

Active Ingredients in each 1 mL (dropperful) Purpose Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant Guaifenesin........................25mg................................................Expectorant Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant

Inactive Ingredients

Inactive ingredients citric acid D and C Red Number 33 FD and C Blue #1 flavor glycerin propylene glycol sodium benzoate sodium saccharin water.

Strengths

1 ml 2.5 mg 25 mg 7.5 mg

Treats Conditions

Other Information Store At Controlled Room Temperature 20 25 C 68 77 F Excursions Permitted To 15 30 C 59 86 F See Usp Controlled Room Temperature Tamper Evident By Imprinted Heat Seal Under Cap Do Not Use If There Is Evidence Of Tampering Oral Dosing Device Enclosed

Identifiers & Packaging

Container Type UNKNOWN

NDC 54859-0603-00

All Product Codes

54859-0603-00 54859-0603-02

UNII

9D2RTI9KYH 495W7451VQ 6V9V2RYJ8N

SPL Set IDs

d915eab8-013e-4ce3-b358-0d531e5ca1ba

Packaging

tusnelDMPed

Package Descriptions

tusnelDMPed

Overview

Other information store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature] Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering Oral dosing device enclosed

Indications & Usage

Dosage & Administration

Directions Do not exceed more than 4 doses in any 24-hour periodor as directed by a doctor. Age Weight Dose Children 2 to under 6 years of age 24 -47 lbs Take 2 mL (two dropperfuls) every 4 to 6 hours Children under 2 years of age Under 24 lbs ask a doctor

Warnings & Precautions

Warnings Do not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving this product.

Purpose

Uses Temporary relief of cough due to minor throat and bronchial irritation. Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive. helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

Do Not Use

Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes a cough that occurs with too much phlegm (mucus) a persistent or chronic cough such as occurs with asthma When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or accompanied by fever cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.

Keep Out of Reach of Children

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

Questions

Questions or Comments? 1-866-595-5598