Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 3f020cf2-6011-4216-9b39-0b3dc5f0749c
Route
ORAL
Published
Effective Date 2018-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Croscarmellose Sodium Fd&c Blue No. 1 Magnesium Stearate Cellulose, Microcrystalline Povidone Stearic Acid Titanium Dioxide Hypromellose, Unspecified Polyethylene Glycol, Unspecified Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ319 Shape: capsule Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

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
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

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
Active Ingredient

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg

Other Information
  • store at room temperature 20°– 25°C (68°– 77°F)
  • do not use if blister is torn or open
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.

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

Questions Or Comments?

Call toll free 1-888-952-0050 Monday through Friday 

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
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

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

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.

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)
Package/label Principal Display Panel
Cold Multi-symptom
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin 
  • taking sedatives or tranquilizers

Structured Label Content

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
Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

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

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
Active Ingredient (Active ingredient)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg

Other Information
  • store at room temperature 20°– 25°C (68°– 77°F)
  • do not use if blister is torn or open
Sore Throat Warning (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.

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

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-952-0050 Monday through Friday 

When Using This Product (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
Liver Warning/allergy Alert (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

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use

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.

Ask A Doctor Before Use If You Have (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)
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Cold Multi-symptom
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin 
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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