Giltuss MultiSymptom Cold and Flu ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE GILTUSS PHARMACEUTICAL CORP FDA Approved Uses temporarily relieves: minor aches and pains headache minor sore throat pain runny nose itchy nose or throat sneezing itchy watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 10 mL) Acetaminophen 650 mg Chlorpheniramine maleate 4 mg Dextromethorphan hydrobromide 13 mg Phenylephrine hydrochloride 10 mg
Inactive Ingredients
Inactive ingredients citric acid disodium EDTA flavor glycerin methylparaben polyethylene glycol propylene glycol propylparaben purified water and sucralose
Strengths
10 ml 650 mg 4 mg 13 mg 10 mg
Quantities
118 ml
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Headache Minor Sore Throat Pain Runny Nose Itchy Nose Or Throat Sneezing Itchy Watery Eyes Due To Hay Fever Nasal And Sinus Congestion Cough Due To Minor Throat And Bronchial Irritation As May Occur With A Cold Temporarily Reduces Fever
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ
Packaging

MAXIMUM STRENGTH Giltuss® MULTI-SYMPTOM COLD & FLU ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE RELIEVES FEVER, HEADACHE AND BODY ACHES COUGH AND COLD SNEEZING RUNNY NOSE ITCHY AND WATERY EYES STUFFY NOSE SINUS PRESSURE STRAWBERRY FLAVOR 4FL OZ (118 mL) 58552-136

Package Descriptions
  • MAXIMUM STRENGTH Giltuss® MULTI-SYMPTOM COLD & FLU ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE RELIEVES FEVER, HEADACHE AND BODY ACHES COUGH AND COLD SNEEZING RUNNY NOSE ITCHY AND WATERY EYES STUFFY NOSE SINUS PRESSURE STRAWBERRY FLAVOR 4FL OZ (118 mL) 58552-136

Overview

Uses temporarily relieves: minor aches and pains headache minor sore throat pain runny nose itchy nose or throat sneezing itchy watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever

Indications & Usage

Uses temporarily relieves: minor aches and pains headache minor sore throat pain runny nose itchy nose or throat sneezing itchy watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever

Dosage & Administration

Directions do not give more than directed use enclosed dosing cup keep dosing cup for use with this product mL = milliliter adults and children 12 years and over 10 mL every 4-6 hours, not to exceed 6 doses in 2 hours children 6 to under 12 years of age 5 mL every 4-6 hours, not to exceed 5 doses in 24 hours children under 6 years of age Do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Purpose

Purposes Pain reliever/fever reducer Antihistamine Cough Suppressant Nasal decongestant

Do Not Use

Do not use if you are allergic to acetaminophen or any inactive ingredient in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 taking this product.

When Using

When using this product do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if you get nervousness, dizzyness or sleeplessness pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. These could be signs 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.


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