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

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
Daytime Cold and Flu
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
Daytime Cold and Flu
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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