Topco Associates Llc. Day Time Nite Time Cold & Flu Relief Drug Facts

Topco Associates Llc. Day Time Nite Time Cold & Flu Relief Drug Facts
SPL v5
SPL
SPL Set ID c00ff684-acaf-4fbe-bc74-7e48751b927d
Route
ORAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg) Phenylephrine (325 mg)
Inactive Ingredients
Alcohol Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Sodium Citrate, Unspecified Form Butylated Hydroxyanisole Edetate Disodium Fd&c Yellow No. 6 Glycerin Sodium Phosphate, Monobasic, Unspecified Form Sucrose Xanthan Gum Menthol, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: red Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-08
Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 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 you take

  • •
    more than 4,000 mg of acetaminophen in 24 hours
  • •
    with other drugs containing acetaminophen
  • •
    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 6 hrs

children 4 to under 12 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.
  • •
    if you have ever had an allergic reaction to this product or any of its ingredients
Other Information
  • •
    each 30 mL dose cup contains: sodium 39 mg
  • •
    store at 20-25°C (68-77°F)
Daytime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Inactive Ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Nighttime Cold & Flu

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

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 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.

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.

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

TopCare® health

COMPARE TO VICKS® DAYQUIL® and VICKS® NYUQUIL® 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

NASAL DECONGESTANT – PHENYLEPHRINE HCl

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

• Nasal Congestion

• Cough

Alcohol Free

Antihistamine Free

Non-Drowsy

ORIGINAL FLAVOR

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 10%

CHERRY FLAVOR

POWERFUL RELIEF DAY OR NIGHT

2 BOTTLES – 1 DAYTIME/1 NIGHTTIME 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 you take

  • •
    more than 4,000 mg of acetaminophen in 24 hours
  • •
    with other drugs containing acetaminophen
  • •
    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 6 hrs

children 4 to under 12 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.
  • •
    if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • •
    each 30 mL dose cup contains: sodium 39 mg
  • •
    store at 20-25°C (68-77°F)
Daytime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Inactive Ingredients (Inactive ingredients)

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Nighttime Cold & Flu

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

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 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.

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.

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)
  • •
    trouble urinating due to an enlarged prostate gland
  • •
    a breathing problem such as emphysema or chronic bronchitis
  • •
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • •
    a sodium-restricted diet
Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare® health

COMPARE TO VICKS® DAYQUIL® and VICKS® NYUQUIL® 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

NASAL DECONGESTANT – PHENYLEPHRINE HCl

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

• Nasal Congestion

• Cough

Alcohol Free

Antihistamine Free

Non-Drowsy

ORIGINAL FLAVOR

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 10%

CHERRY FLAVOR

POWERFUL RELIEF DAY OR NIGHT

2 BOTTLES – 1 DAYTIME/1 NIGHTTIME 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

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Source: dailymed · Ingested: 2026-02-15T12:09:02.906482 · Updated: 2026-03-14T23:13:37.162375