Supervalu Inc. Daytime & Nighttime Cold & Flu Relief Drug Facts

Supervalu Inc. Daytime & Nighttime Cold & Flu Relief Drug Facts
SPL v9
SPL
SPL Set ID 8fc2389c-9657-4dbe-a32b-df8245fc67ca
Route
ORAL
Published
Effective Date 2023-06-26
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 D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Yellow No. 6 High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Sodium Citrate, Unspecified Form Butylated Hydroxyanisole Edetate Disodium Glycerin Sodium Phosphate, Monobasic, Unspecified Form Sucrose Xanthan Gum Menthol, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: green Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-14

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 38 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, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, 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?

1-855-423-2630

Principal Display Panel

EQUALINE®

cold & flu combo pack

compare to Vicks® DayQuil® Cold & Flu active ingredients

EQUALINE®

daytime cold & flu relief

acetaminophen (pain reliever/fever reducer)

dextromethorphan HBr (cough suppressant)

phenylephrine HCl (nasal decongestant)

powerful daytime relief

multi-symptom

relieves:

• aches, fever & sore throat

• nasal congestion

• coughs

original flavor

ALCOHOL FREE • ANTIHISTAMINE FREE

compare to Vicks® NyQuil® Cold & Flu active ingredients

EQUALINE®

nighttime cold & flu relief

acetaminophen (pain reliever/fever reducer)

dextromethorphan HBr (cough suppressant)

doxylamine succinate (antihistamine)

powerful nighttime relief

relieves:

• aches & fever

• runny nose

• sneezing

• cough

original flavor

ALCOHOL 10%

12 FL OZ (355mL) + 12 FL OZ (355mL) = 24 FL OZ (1.5pt) 710mL

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 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:

  • 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 38 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, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, 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?)

1-855-423-2630

Principal Display Panel

EQUALINE®

cold & flu combo pack

compare to Vicks® DayQuil® Cold & Flu active ingredients

EQUALINE®

daytime cold & flu relief

acetaminophen (pain reliever/fever reducer)

dextromethorphan HBr (cough suppressant)

phenylephrine HCl (nasal decongestant)

powerful daytime relief

multi-symptom

relieves:

• aches, fever & sore throat

• nasal congestion

• coughs

original flavor

ALCOHOL FREE • ANTIHISTAMINE FREE

compare to Vicks® NyQuil® Cold & Flu active ingredients

EQUALINE®

nighttime cold & flu relief

acetaminophen (pain reliever/fever reducer)

dextromethorphan HBr (cough suppressant)

doxylamine succinate (antihistamine)

powerful nighttime relief

relieves:

• aches & fever

• runny nose

• sneezing

• cough

original flavor

ALCOHOL 10%

12 FL OZ (355mL) + 12 FL OZ (355mL) = 24 FL OZ (1.5pt) 710mL

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 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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