417- Daytime Cold And Flu
bed5f9dc-45ea-4e90-86c6-86599b6f3861
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg
Purpose
Pain reliever/fever reducer Cough suppressant Nasal decongestant
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Description
Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg
Use(s)
temporarily relieves common cold and flu symptoms: ■ nasal congestion ■ cough due to minor throat and bronchial irritation ■ sore throat ■ headache ■ minor aches and pains ■ fever
Storage
store at room temperature 20-25 °C (68-77° F)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses 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, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Questions
Call 1-888-952-0050 Monday through Friday
Directions
take only as directed
- do not exceed 4 doses per 24 hours
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- Children 4 to under 12 years: ask a doctor
- Children under 4 years: 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Other Information
do not use if blister unit is torn or open
Active Ingredient(s)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink
Pregnancy/breastfeeding
ask a health professional before use.
Principal Display Panel
When Using This Product
do not use more than directed
Ask A Doctor Before Use If
■ 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)
Stop Use and Ask A Doctor If
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- fever gets worse or lasts more than 3 days n redness or swelling is present
- new symptoms occurs
- 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
Taking more than directed can cause serious health problems. 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 Or Pharmacist Before Use If
taking the blood thinning drug warfarin.
Structured Label Content
Use(s)
temporarily relieves common cold and flu symptoms: ■ nasal congestion ■ cough due to minor throat and bronchial irritation ■ sore throat ■ headache ■ minor aches and pains ■ fever
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Storage
store at room temperature 20-25 °C (68-77° F)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses 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, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Questions
Call 1-888-952-0050 Monday through Friday
Directions
take only as directed
- do not exceed 4 doses per 24 hours
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- Children 4 to under 12 years: ask a doctor
- Children under 4 years: do not use
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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Other Information (Other information)
do not use if blister unit is torn or open
Active Ingredient(s) (Active ingredient(s))
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Inactive Ingredients (Inactive ingredients)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink
Pregnancy/breastfeeding (Pregnancy/Breastfeeding)
ask a health professional before use.
Principal Display Panel
When Using This Product (When using this product)
do not use more than directed
Ask A Doctor Before Use If (Ask a doctor before use if)
■ 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)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- fever gets worse or lasts more than 3 days n redness or swelling is present
- new symptoms occurs
- 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)
Taking more than directed can cause serious health problems. 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 Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
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: 2026-02-15T12:02:21.498608 · Updated: 2026-03-14T23:01:51.692931