Cvs Dt & Nt Combo Pack Cold & Flu

Cvs Dt & Nt Combo Pack Cold & Flu
SPL v6
SPL
SPL Set ID 360c8c62-0945-4031-b291-d40c4270b940
Route
ORAL
Published
Effective Date 2023-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Yellow No. 6 Glycerin Menthol, Unspecified Form Potassium Citrate Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum D&c Yellow No. 10 Fd&c Green No. 3 Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-20

Description

CVS DayTime Cold & Flu Relief

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Description

CVS DayTime Cold & Flu Relief

Uses
  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
Section 42229-5

CVS DayTime Cold & Flu Relief

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 6 to under 12 yrs

15 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

  • adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 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 15 mL contains:

  • sodium 42 mg
  • store at room temperature
  • Do not refrigerate.
Inactive Ingredients

Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

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
  • 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 5 days (children) or 7 days (adult)
  • 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 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have
  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • A sodium-restricted diet
Principal Display Panel Kit Carton

Compare to the active ingredients in Vicks®DayQuil™ Cold & Flu*

NDC# 51316-618-12

DayTime

Cold & Flu

Relief

Acetaminophen,Dextromethorphan HBr,

Phenylephrine HCl

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal Congestion & Sinus Pressure
  • Cough

Compare to the active ingredients in Vicks®NyQuil™ Cold & Flu*

NightTime

Cold & Flu

Relief

Acetaminophen,Dextromethorphan HBr

Dextromethorphan HBr

  • headache, Fever, Sore Throat,
  • Minor Aches & Pains
  • Sneezing, Runny Nose
  • Cough

Original Flavor

Tamper Evident: Do not use if imprinted shrink band is missing or broken.

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

*These product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ and Vicks® Nyquil™ Cold & flu.

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
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
Section 42229-5 (42229-5)

CVS DayTime Cold & Flu Relief

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

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 6 to under 12 yrs

15 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

  • adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 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 15 mL contains:

  • sodium 42 mg
  • store at room temperature
  • Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

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)
  • 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 5 days (children) or 7 days (adult)
  • 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 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

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
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • A sodium-restricted diet
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

Compare to the active ingredients in Vicks®DayQuil™ Cold & Flu*

NDC# 51316-618-12

DayTime

Cold & Flu

Relief

Acetaminophen,Dextromethorphan HBr,

Phenylephrine HCl

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal Congestion & Sinus Pressure
  • Cough

Compare to the active ingredients in Vicks®NyQuil™ Cold & Flu*

NightTime

Cold & Flu

Relief

Acetaminophen,Dextromethorphan HBr

Dextromethorphan HBr

  • headache, Fever, Sore Throat,
  • Minor Aches & Pains
  • Sneezing, Runny Nose
  • Cough

Original Flavor

Tamper Evident: Do not use if imprinted shrink band is missing or broken.

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

*These product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ and Vicks® Nyquil™ Cold & flu.

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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