Cold Multi-Symptom Night-time ACETAMINOPHENCHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI ALLEGIANT HEALTH FDA Approved Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sneezing and runny nose sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg
Inactive Ingredients
Inactive Ingredients corn starch crospovidone croscarmellose sodium FD&C blue #1 aluminum lake hypromellose magnesium stearate microcrystalline cellulose povidone pregelatinized starch polyethylene glycol silicon dioxide stearic acid itanium dioxide May contain: FD&C lake black
Strengths
325 mg 2 mg 10 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Common Cold Flu Symptoms Minor Aches And Pains Headache Sore Throat Nasal Congestion Cough Sneezing And Runny Nose Sinus Congestion And Pressure Helps Clear Nasal Passages Relieves Cough To Help You Sleep Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: blue Imprint: AZ319

Identifiers & Packaging

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

Package/Label Principal Display Panel Cold Multi-symptom Cold Multi-symptom

Package Descriptions
  • Package/Label Principal Display Panel Cold Multi-symptom Cold Multi-symptom

Overview

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sneezing and runny nose sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sneezing and runny nose sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see Overdose Warnings) Adults and children 12 years and over: take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than a total of 10 caplets in 24 hours Children under 12 years: ask a doctor

Warnings & Precautions
Warnings Liver warning/Allergy alert Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help immediately Sore throat warning 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. Do Not Use 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage. excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs 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 rash or headache that lasts These could be signs of a serious condition If pregnant or breast-feeding ask a health professional before use
Purpose

Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Do Not Use

Do Not Use 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. if you have ever had an allergic reaction to this product or any of its ingredients

When Using

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

Stop Use & Ask a Doctor

Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs 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 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 Overdose warning: In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 toll free 1-888-952-0050 Monday through Friday


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