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

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


Medication Information

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.

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

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

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

Description

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

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

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
Questions Or Comments?

1-888-287-1915

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

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.

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

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

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

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

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
Questions Or Comments? (Questions or comments?)

1-888-287-1915

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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