Meijer Distribution, Inc. Daytime Nitetime Cold & Flu Drug Facts

Meijer Distribution, Inc. Daytime Nitetime Cold & Flu Drug Facts
SPL v8
SPL
SPL Set ID 80aae1c3-a616-442b-842e-177db957a69c
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 Menthol, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-10-24

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 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?

1-800-719-9260

Principal Display Panel

meijer®

COMBO PACK

POWERFUL RELIEF

meijer®

MAXIMUM STRENGTH

NON-DROWSY

DayTime Cold & Flu

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

RELIEVES: ACHES, PAIN, FEVER, COUGH, NASAL CONGESTION, SORE THROAT

Alcohol Free

meijer®

MAXIMUM STRENGTH

NiteTime Cold & Flu

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant) | Doxylamine Succinate (Antihistamine)

COMPARE TO VICKS® NYQUIL® COLD & FLU ACTIVE INGREDIENTS

RELIEVES: ACHES, PAIN, FEVER, SORE THROAT, SNEEZING, RUNNY NOSE, COUGH

CHERRY FLAVOR

ALCOHOL 10%

MULTI-SYMPTOM | COLD & FLU

2 – 12 FL OZ (355 mL) BOTTLES – TOTAL 24 FL OZ (1.5 pt) (710 mL)

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)
  • 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
  • a sodium-restricted diet
Ask Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Ask A Doctor Or Pharmacist Before Use If You Are

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 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?)

1-800-719-9260

Principal Display Panel

meijer®

COMBO PACK

POWERFUL RELIEF

meijer®

MAXIMUM STRENGTH

NON-DROWSY

DayTime Cold & Flu

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

RELIEVES: ACHES, PAIN, FEVER, COUGH, NASAL CONGESTION, SORE THROAT

Alcohol Free

meijer®

MAXIMUM STRENGTH

NiteTime Cold & Flu

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant) | Doxylamine Succinate (Antihistamine)

COMPARE TO VICKS® NYQUIL® COLD & FLU ACTIVE INGREDIENTS

RELIEVES: ACHES, PAIN, FEVER, SORE THROAT, SNEEZING, RUNNY NOSE, COUGH

CHERRY FLAVOR

ALCOHOL 10%

MULTI-SYMPTOM | COLD & FLU

2 – 12 FL OZ (355 mL) BOTTLES – TOTAL 24 FL OZ (1.5 pt) (710 mL)

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

taking the blood thinning drug warfarin


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