474 - daytime cold and flu relief

474 - daytime cold and flu relief
SPL v1
SPL
SPL Set ID 69ed2da0-16b2-49eb-91b4-cc5cf328c817
Route
oral
Published
Effective Date 2026-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol 400 povidone k12 propylene glycol water sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: P41 Shape: capsule Color: orange Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2026-01-09

Purpose

Pain reliever/fever reducer Cough suppressant

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg


Medication Information

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.

Purpose

Pain reliever/fever reducer

Cough suppressant

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
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

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg

Principal Display Panel
Daytime Cold and Flu
Use(s)

temporarily relieves these symptoms due to cold flu:

  • cough
  • sore throat
  • headache
  • minor aches and pains
  • temporarily reduces fever
Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

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
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

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.

Purpose

Pain reliever/fever reducer

Cough suppressant

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
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

Principal Display Panel
Daytime Cold and Flu
Use(s)

temporarily relieves these symptoms due to cold flu:

  • cough
  • sore throat
  • headache
  • minor aches and pains
  • temporarily reduces fever
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

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
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.


Advanced Ingredient Data


Raw Label Data

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