324 - Health A2z Cold Multi-symptom

324 - Health A2z Cold Multi-symptom
SPL v5
SPL
SPL Set ID 9a4c0c43-a71a-4e22-a3d5-9eb9622689a2
Route
ORAL
Published
Effective Date 2019-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Crospovidone Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Silicon Dioxide Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ;324 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-15

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer Cough supressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough supressant

Nasal decongestant

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains 

■ headache 

■ sore throat  

■ nasal congestion 

■ cough  

■ sinus congestion and pressure 

■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 

■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take: 

■ more than 12 caplets in 24 hours, which is the maximum daily amount 

■ with other drugs containing acetaminophen

■ 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 

If a skin reaction occurs, stop use and seek medical help immediately

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.

Directions

do not take more than directed (see Warnings)

Adults and children 12 years and over: 

■ take 2 caplets every 4 hours   

■ do not take more than 12 caplets in 24 hours 

Children under 12 years: do not use this adult product in children under 12 years of age.

This will provide more than the recommended dose (overdose) and may cause liver damage

Do Not Use

■ with any other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist  n 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 drugs. If you do not know if your prescription drugs contains an MAOI, ask a doctor or pharmacist.

Other Information

■ store between 15-30°C (59-86°F) 

■ do not use if blister is torn or open

Active Ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropylmethylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions Or Comments?

Call toll free 1-888-952-0050

Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

 

Cold Multi-Symptom

When Using This Product

When using this product do not exceed recommended dosage

Stop Use and Ask A Doctor If

Stop use and ask a doctor if        

■ nervousness, dizziness or sleeplessness occurs 

■ pain gets worse or lasts more than 7 days n fever gets worse or lasts more than 3 days  

■ redness or swelling is present  n 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. 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 Are

taking the blood thinning drug warfarin

Ask A Doctor Before Use If You Have

■ liver disease 

■ heart disease n 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 n cough that occurs with too much phlegm (mucus)


Structured Label Content

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains 

■ headache 

■ sore throat  

■ nasal congestion 

■ cough  

■ sinus congestion and pressure 

■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 

■ temporarily reduces fever

Purpose

Pain reliever/fever reducer

Cough supressant

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take: 

■ more than 12 caplets in 24 hours, which is the maximum daily amount 

■ with other drugs containing acetaminophen

■ 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 

If a skin reaction occurs, stop use and seek medical help immediately

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.

Directions

do not take more than directed (see Warnings)

Adults and children 12 years and over: 

■ take 2 caplets every 4 hours   

■ do not take more than 12 caplets in 24 hours 

Children under 12 years: do not use this adult product in children under 12 years of age.

This will provide more than the recommended dose (overdose) and may cause liver damage

Do Not Use (Do not use)

■ with any other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist  n 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 drugs. If you do not know if your prescription drugs contains an MAOI, ask a doctor or pharmacist.

Other Information (Other information)

■ store between 15-30°C (59-86°F) 

■ do not use if blister is torn or open

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropylmethylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-952-0050

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

 

Cold Multi-Symptom

When Using This Product (When using this product)

When using this product do not exceed recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if        

■ nervousness, dizziness or sleeplessness occurs 

■ pain gets worse or lasts more than 7 days n fever gets worse or lasts more than 3 days  

■ redness or swelling is present  n 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)

Keep out of reach of children. 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 Are (Ask a doctor before use if you are)

taking the blood thinning drug warfarin

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ liver disease 

■ heart disease n 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 n cough that occurs with too much phlegm (mucus)


Advanced Ingredient Data


Raw Label Data

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