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

Description

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

Purpose

Pain reliever/fever reducer Cough Suppressant Nasal Decongestant


Medication Information

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

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
Section 50565-1

Keep out of reach of children.

Section 51945-4

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
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 

Drug Facts

Active ingredients (in each 15 mL dose cup)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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

Inactive Ingredients

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

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

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
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

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
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 

Drug Facts

Active ingredients (in each 15 mL dose cup)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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
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.

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

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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