Topco Associates Llc. Cold & Flu Relief Drug Facts

Topco Associates Llc. Cold & Flu Relief Drug Facts
SPL v2
SPL
SPL Set ID 560fb22b-391f-4d7b-a6fd-38d577d404b0
Route
ORAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-27
Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Uses
  • •
    temporarily relieves common cold/flu symptoms:
  • •
    cough due to minor throat and bronchial irritation
  • •
    sore throat
  • •
    headache
  • •
    minor aches and pains
  • •
    fever
  • •
    runny nose and sneezing
Warnings

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

  • •
    adult takes more than 4,000 mg of acetaminophen in 24 hours
  • •
    child takes more than 5 doses in 24 hours
  • •
    taken with other drugs containing acetaminophen
  • •
    adult has 3 or more alcoholic drinks every day while using this product

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.

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.

Directions
  • •
    take only as directed – see Overdose warning
  • •
    only use the dose cup provided
  • •
    do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use
Do Not Use
  • •
    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.
  • •
    to make a child sleepy
  • •
    if you have ever had an allergic reaction to this product or any of its ingredients
Other Information
  • •
    each 15 mL contains: sodium 12 mg
  • •
    store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-888-423-0139

When Using This Product
  • •
    excitability may occur, especially in children
  • •
    marked drowsiness may occur
  • •
    avoid alcoholic drinks
  • •
    be careful when driving a motor vehicle or operating machinery
  • •
    alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • •
    pain or cough gets worse or lasts 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.

Keep Out of Reach of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Before Use If You Have
  • •
    liver disease
  • •
    glaucoma
  • •
    cough that occurs with too much phlegm (mucus)
  • •
    a breathing problem such as emphysema or chronic bronchitis
  • •
    trouble urinating due to an enlarged prostate gland
  • •
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel

TopCare® health

COMPARE TO VICKS® DAYQUIL® and VICKS® NYQUIL® ACTIVE INGREDIENTS

Cold & Flu Relief

DAY & NIGHT COMBO PACK

TopCare® health

COMPARE TO VICKS® DAYQUIL® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

DayTime

Cold & Flu Relief

PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Cough

Alcohol Free

Antihistamine Free

Non-Drowsy

TopCare® health

COMPARE TO VICKS® NYQUIL® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

NiteTime

Cold & Flu Relief

PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Sneezing, Runny Nose

• Cough

Alcohol Free

ELDERBERRY FLAVOR

POWERFUL RELIEF DAY OR NIGHT

2 BOTTLES-1 DAYTIME/1 NITETIME 12 FL OZ (355 mL) EACH; TOTAL 24 FL OZ (1.5 pt) (710 mL)

Ask A Doctor Or Pharmacist Before Use If You Are
  • •
    taking sedatives or tranquilizers
  • •
    taking the blood thinning drug warfarin

Structured Label Content

Uses
  • •
    temporarily relieves common cold/flu symptoms:
  • •
    cough due to minor throat and bronchial irritation
  • •
    sore throat
  • •
    headache
  • •
    minor aches and pains
  • •
    fever
  • •
    runny nose and sneezing
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Warnings

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

  • •
    adult takes more than 4,000 mg of acetaminophen in 24 hours
  • •
    child takes more than 5 doses in 24 hours
  • •
    taken with other drugs containing acetaminophen
  • •
    adult has 3 or more alcoholic drinks every day while using this product

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.

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.

Directions
  • •
    take only as directed – see Overdose warning
  • •
    only use the dose cup provided
  • •
    do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use
Do Not Use (Do not use)
  • •
    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.
  • •
    to make a child sleepy
  • •
    if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • •
    each 15 mL contains: sodium 12 mg
  • •
    store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (When using this product)
  • •
    excitability may occur, especially in children
  • •
    marked drowsiness may occur
  • •
    avoid alcoholic drinks
  • •
    be careful when driving a motor vehicle or operating machinery
  • •
    alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • •
    pain or cough gets worse or lasts 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.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • •
    liver disease
  • •
    glaucoma
  • •
    cough that occurs with too much phlegm (mucus)
  • •
    a breathing problem such as emphysema or chronic bronchitis
  • •
    trouble urinating due to an enlarged prostate gland
  • •
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare® health

COMPARE TO VICKS® DAYQUIL® and VICKS® NYQUIL® ACTIVE INGREDIENTS

Cold & Flu Relief

DAY & NIGHT COMBO PACK

TopCare® health

COMPARE TO VICKS® DAYQUIL® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

DayTime

Cold & Flu Relief

PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Cough

Alcohol Free

Antihistamine Free

Non-Drowsy

TopCare® health

COMPARE TO VICKS® NYQUIL® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

NiteTime

Cold & Flu Relief

PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Sneezing, Runny Nose

• Cough

Alcohol Free

ELDERBERRY FLAVOR

POWERFUL RELIEF DAY OR NIGHT

2 BOTTLES-1 DAYTIME/1 NITETIME 12 FL OZ (355 mL) EACH; TOTAL 24 FL OZ (1.5 pt) (710 mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • •
    taking sedatives or tranquilizers
  • •
    taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:57.666240 · Updated: 2026-03-14T23:13:28.374847