474 - Daytime Cold And Flu Relief
69ed2da0-16b2-49eb-91b4-cc5cf328c817
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325mg Dextromethorphan HBr 10mg
Purpose
Pain reliever/fever reducer Cough suppressant
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Description
Acetaminophen 325mg Dextromethorphan HBr 10mg
Use(s)
temporarily relieves these symptoms due to cold flu:
- cough
- sore throat
- headache
- minor aches and pains
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
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.
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 right away.
Directions
- do not take more than the recommended dose
Adults and children 12 years and over: Take 2 softgels with water every 4 hours. Do not exceed 8 softgels in 24 hours or as directed by a doctor
Children under 12 years: Do not use
Other Information
- store at room temperature 20-25°C (68-77°F)
- avoid excessive heat
- do not use if blister unit is torn or open
Questions/comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Active Ingredient(s)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12,
Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White Edible Ink
Do Not Use If You Have
- 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
- in children under 12 years of age
Principal Display Panel
When Using This Product
do not exceed recommended dosage.
Stop Use and Ask A Doctor If
• pain, 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.
• nervousness, dizziness, or sleeplessness occurs
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)
right away. 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough with excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If
if you are taking the blood thinning drug warfarin.
Structured Label Content
Use(s)
temporarily relieves these symptoms due to cold flu:
- cough
- sore throat
- headache
- minor aches and pains
- temporarily reduces fever
Purpose
Pain reliever/fever reducer
Cough suppressant
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
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.
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 right away.
Directions
- do not take more than the recommended dose
Adults and children 12 years and over: Take 2 softgels with water every 4 hours. Do not exceed 8 softgels in 24 hours or as directed by a doctor
Children under 12 years: Do not use
Other Information (Other information)
- store at room temperature 20-25°C (68-77°F)
- avoid excessive heat
- do not use if blister unit is torn or open
Questions/comments (Questions/Comments)
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Active Ingredient(s) (Active ingredient(s))
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Inactive Ingredients (Inactive ingredients)
FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12,
Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White Edible Ink
Do Not Use If You Have (Do not use if you have)
- 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
- in children under 12 years of age
Principal Display Panel
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)
• pain, 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.
• nervousness, dizziness, or sleeplessness occurs
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)
ask a health professional before use.
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 (1-800-222-1222)
right away. 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 (Ask a doctor before use if you)
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough with excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
if you are taking the blood thinning drug warfarin.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:14.714806 · Updated: 2026-03-14T23:12:25.780176