Cvs Daytime & Nighttime Cold & Flu Combo Pack

Cvs Daytime & Nighttime Cold & Flu Combo Pack
SPL v5
SPL
SPL Set ID 4c813cd5-2c97-4fc3-926c-1a0396551a31
Route
ORAL
Published
Effective Date 2023-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Yellow No. 10 Edetate Disodium Fd&c Blue No. 1 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-10

Description

DayTime Cold & Flu

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

DayTime Cold & Flu

Uses
  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5

DayTime Cold & Flu

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50567-7

When using this product, do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions
  • take only as directed
  • Only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hours

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.
Questions?

1-866-467-2748

Liver Warning

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • taken 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

Other Information

each 30 mL contains:

  • sodium 81 mg
  • store at room temperature
  • Do not refrigerate.
Inactive Ingredients

Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No.1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

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.

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 & tranquilizers may increase drowsiness
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.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients (in Each Caplet)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Principal Display Panel Kit Carton

**Compare to the active ingredients in Vicks®DayQuil™ Severe+ VapoCOOL™

NDC# 51316-156-24

DayTime

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Dextromethorphan HBr – Cough suppressant

Guaifenesin - Expectorant

Phenylephrine HCl – Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

*Compare to the active ingredients in Vicks®NyQuil™ Severe+ VapoCOOL™

NightTime

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Dextromethorphan HBr – Cough suppressant

Phenylephrine HCl - Antihistamine

Phenylephrine HCl – Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

TWO BOTTLES, 12 FL OZ (354 mL) each; TOTAL 24 FL OZ (708 mL)

**This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ Severe+ VapoCOOL™ and Vicks® Nyquil™ Severe+ VapoCOOL™


Structured Label Content

Uses
  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5 (42229-5)

DayTime Cold & Flu

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50567-7 (50567-7)

When using this product, do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • take only as directed
  • Only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hours

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.
Questions?

1-866-467-2748

Liver Warning (Liver warning)

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • taken 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

Other Information (Other information)

each 30 mL contains:

  • sodium 81 mg
  • store at room temperature
  • Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No.1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Sore Throat Warning: (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.

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 & tranquilizers may increase drowsiness
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.

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

**Compare to the active ingredients in Vicks®DayQuil™ Severe+ VapoCOOL™

NDC# 51316-156-24

DayTime

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Dextromethorphan HBr – Cough suppressant

Guaifenesin - Expectorant

Phenylephrine HCl – Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

*Compare to the active ingredients in Vicks®NyQuil™ Severe+ VapoCOOL™

NightTime

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Dextromethorphan HBr – Cough suppressant

Phenylephrine HCl - Antihistamine

Phenylephrine HCl – Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

TWO BOTTLES, 12 FL OZ (354 mL) each; TOTAL 24 FL OZ (708 mL)

**This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ Severe+ VapoCOOL™ and Vicks® Nyquil™ Severe+ VapoCOOL™


Advanced Ingredient Data


Raw Label Data

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