Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 0f9d1fc6-2dfe-4e2d-9a71-b7bc72accc87
Route
ORAL
Published
Effective Date 2026-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Trisodium Citrate Dihydrate Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-12-04 Until 2027-06-04

Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg


Medication Information

Warnings and Precautions

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
  • child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

Allery 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

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.



Indications and Usage
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Dosage and Administration
  • do not take more than directed (see overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL=milliliter
adults and children 12 years and over 30 mL every 4 hours 
children 6 to under 12 years  15 mL every 4 hours 
children 4 to under 6 years   ask a doctor 
children under 4 years   do not use 
  • When using Daytime or Nighttime products, carefully read each label to ensure correct dosing
Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg

Section 50565-1

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Section 50566-9
  • pain, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • fever gets worse, or lasts more 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.

Section 50567-7

do not exceed recommended dosage.

Section 50568-5

taking the blood thinning drug warfarin.

Section 50569-3
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs by excessive phlegm (mucus)
Section 50570-1
  • if you are allergic to acetaminophen
  • 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.
Section 51727-6

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4

MULTI-SYMPTOM

Daytime

Cold & Flu Relief

ACETAMINOPHEN 325 mg

PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr 10 mg

COUGH SUPPRESSANT

For relief of:

  • Aches, fever & sore throat
  • Cough

FOR AGES 6 YEARS & OVER

ALCOHOL FREE

ANTIHISTAMINEFREE

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

Section 53413-1

Call

Section 53414-9

ask a health professional before use.

Section 55105-1

Pain reliever/fever reducer

Cough suppressant

Section 55106-9

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Section 60561-8
  • each 15 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate

Structured Label Content

Indications and Usage (34067-9)
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Dosage and Administration (34068-7)
  • do not take more than directed (see overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL=milliliter
adults and children 12 years and over 30 mL every 4 hours 
children 6 to under 12 years  15 mL every 4 hours 
children 4 to under 6 years   ask a doctor 
children under 4 years   do not use 
  • When using Daytime or Nighttime products, carefully read each label to ensure correct dosing
Warnings and Precautions (34071-1)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
  • child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

Allery 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

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.



Section 50565-1 (50565-1)

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Section 50566-9 (50566-9)
  • pain, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • fever gets worse, or lasts more 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.

Section 50567-7 (50567-7)

do not exceed recommended dosage.

Section 50568-5 (50568-5)

taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs by excessive phlegm (mucus)
Section 50570-1 (50570-1)
  • if you are allergic to acetaminophen
  • 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.
Section 51727-6 (51727-6)

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4 (51945-4)

MULTI-SYMPTOM

Daytime

Cold & Flu Relief

ACETAMINOPHEN 325 mg

PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr 10 mg

COUGH SUPPRESSANT

For relief of:

  • Aches, fever & sore throat
  • Cough

FOR AGES 6 YEARS & OVER

ALCOHOL FREE

ANTIHISTAMINEFREE

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

Section 53413-1 (53413-1)

Call

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Cough suppressant

Section 55106-9 (55106-9)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Section 60561-8 (60561-8)
  • each 15 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate

Advanced Ingredient Data


Raw Label Data

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