Wal-mart Daytime Nighttime Cold & Flu Drug Facts

Wal-mart Daytime Nighttime Cold & Flu Drug Facts
SPL v5
SPL
SPL Set ID 4173ecde-a2d7-4836-a6e9-fef2270d1b4e
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Doxylamine (12.5 mg) Phenylephrine (10 mg) Guaifenesin (325 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose Xanthan Gum Butylated Hydroxyanisole Fd&c Yellow No. 6 Menthol, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Polyethylene Glycol, Unspecified Sucrose

Identifiers & Packaging

Pill Appearance
Color: red Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-18

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
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 4 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 41 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-888-287-1915

Principal Display Panel

VALUE PACK

equate

equate

Compare to Vicks® DayQuil® Severe active ingredients

DAYTIME

NON-DROWSY

SEVERE

Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

MAXIMUM STRENGTH

Daytime Relief

• Acetaminophen – Headache, fever, sore throat, minor aches & pains

• Dextromethorphan HBr – Cough

• Guaifenesin – Chest congestion

• Phenylephrine HCl – Nasal/sinus congestion & sinus pressure

Alcohol Free

12 FL OZ (355mL)

equate

Compare to Vicks® NyQuil® Severe active ingredients

NIGHTTIME

SEVERE

Cold & Flu

Pain Reliever, Fever Reducer, Nasal Decongestant, Cough Suppressant, Antihistamine

MAXIMUM STRENGTH

Nighttime Relief

• Acetaminophen – Headache, fever, sore throat, minor aches & pains

• Dextromethorphan HBr – Cough

• Doxylamine Succinate – Sneezing, runny nose

• Phenylehprine HCl – Nasal/sinus congestion & sinus pressure

12 FL OZ (355mL)

Berry flavor

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

When Using This Product
  • do not use more than directed
  • 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
Daytime Severe Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Nighttime Severe Cold & Flu

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 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:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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 4 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 41 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel

VALUE PACK

equate

equate

Compare to Vicks® DayQuil® Severe active ingredients

DAYTIME

NON-DROWSY

SEVERE

Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

MAXIMUM STRENGTH

Daytime Relief

• Acetaminophen – Headache, fever, sore throat, minor aches & pains

• Dextromethorphan HBr – Cough

• Guaifenesin – Chest congestion

• Phenylephrine HCl – Nasal/sinus congestion & sinus pressure

Alcohol Free

12 FL OZ (355mL)

equate

Compare to Vicks® NyQuil® Severe active ingredients

NIGHTTIME

SEVERE

Cold & Flu

Pain Reliever, Fever Reducer, Nasal Decongestant, Cough Suppressant, Antihistamine

MAXIMUM STRENGTH

Nighttime Relief

• Acetaminophen – Headache, fever, sore throat, minor aches & pains

• Dextromethorphan HBr – Cough

• Doxylamine Succinate – Sneezing, runny nose

• Phenylehprine HCl – Nasal/sinus congestion & sinus pressure

12 FL OZ (355mL)

Berry flavor

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

When Using This Product (When using this product)
  • do not use more than directed
  • 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
Daytime Severe Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Nighttime Severe Cold & Flu

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 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

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