Drug Facts
3f020cf2-6011-4216-9b39-0b3dc5f0749c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
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)
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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:20.768984 · Updated: 2026-03-14T23:01:50.647319