dayttime cold & flu

dayttime cold & flu
SPL v1
SPL
SPL Set ID 0609120e-c348-494e-b4a0-863e77d7963a
Route
oral
Published
Effective Date 2025-05-20
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
citric acid fd&c yellow no. 6 glycerin menthol propylene glycol water sodium benzoate sorbitol solution sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
otc monograph drug active Since 2025-05-01

Purpose

Pain reliever/fever reducer Cough Suppressant Nasal Decongestant

Description

Active ingredients (in each 15 mL dose cup) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg


Medication Information

Warnings

Liver warning:This product contains acetaminophen. Sever liver damage may occur if:

  • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • children 6 to 12 years of age take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • take with other drug containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause sever skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • ras

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is sever, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), 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.
  • If you have ever had an allergic reaction to this product or any o its ingredients
Uses

temporarily relieves common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation
Purpose

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Directions
  • take only as directed (see Overdose warning)
  • measure only with dose cup provided and keep dose cup with product 
  • mL=mililiter
  • do not exceed 4 doses per 24 hours
Age Dose
adults & children 12 years and over 30 mL every 4 hours
 children 6 to under 12 years 15 mL every 4 hours
 children under 6 years do not use 

Other Information
  • each 15 mL contains:sodium 5 mg
  • store at room temperature 15-30°C (59-86°C) and do not refrigerate
Inactive Ingredients

Citric acid, FD&C Yellow No 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Description

Active ingredients (in each 15 mL dose cup) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Section 50565-1

Keep out of reach of children.

Section 51945-4

Drug Facts

Active ingredients (in each 15 mL dose cup)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Overdose Warning:

Taking more than the recommended dose (overdose) may cause serious health problemas including liver damamge. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if ou do not notice any signs or symptoms.

Questions Or Comments?

1-844-912-4012

When Using This Product
  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • diabete
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough accompanied by excessive phlegm (mucus)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Warnings

Liver warning:This product contains acetaminophen. Sever liver damage may occur if:

  • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • children 6 to 12 years of age take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • take with other drug containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause sever skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • ras

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is sever, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), 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.
  • If you have ever had an allergic reaction to this product or any o its ingredients
Uses

temporarily relieves common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation
Purpose

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Directions
  • take only as directed (see Overdose warning)
  • measure only with dose cup provided and keep dose cup with product 
  • mL=mililiter
  • do not exceed 4 doses per 24 hours
Age Dose
adults & children 12 years and over 30 mL every 4 hours
 children 6 to under 12 years 15 mL every 4 hours
 children under 6 years do not use 

Other Information (Other information)
  • each 15 mL contains:sodium 5 mg
  • store at room temperature 15-30°C (59-86°C) and do not refrigerate
Inactive Ingredients (Inactive ingredients)

Citric acid, FD&C Yellow No 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Drug Facts

Active ingredients (in each 15 mL dose cup)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Overdose Warning: (Overdose warning:)

Taking more than the recommended dose (overdose) may cause serious health problemas including liver damamge. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if ou do not notice any signs or symptoms.

Questions Or Comments? (Questions or Comments?)

1-844-912-4012

When Using This Product (When using this product)
  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • diabete
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough accompanied by excessive phlegm (mucus)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

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.


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