Walgreens Non-drowsy Daytime Cold & Flu

Walgreens Non-drowsy Daytime Cold & Flu
SPL v7
SPL
SPL Set ID ec8c73d5-b190-432a-92c6-68ea0fc86ea6
Route
ORAL
Published
Effective Date 2021-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: 512;A09 Shape: oval Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-23 Until 2026-12-31

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.

Section 50570-1

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.
Section 53414-9

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

Section 55105-1
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan Hydrobromide 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
  • Take only as directed—see Overdose warning.
  • do not exceed 4 doses per 24 hours.
adults and children 12 years of age and over swallow 2 softgels with water every 4 hours
children 4 to under 12 years of age ask a doctor
children under 4 years of age do not use

When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.

Other Information
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Inactive Ingredients

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

COMPARE TO



VICKS ® DAYQUIL ®LiquiCaps® ACTIVE INGREDIENTS††

Walgreens

DAYTIME NON-DROWSY

Cold & Flu

Acetaminophen325mg/ ACHES/ FEVER/ SORE THROAT



Dextromethorphan HBr 10mg/ COUGH



Phenylephrine HCl5mg/ NASAL CONGESTION



Relieves aches, fever, sore throat, nasal congestion & cough

Actual Size

24 softgels

†† This product is not manufactured or distributed by



Procter & Gamble, owner of the registered



trademarks Vicks® DayQuil® LiquiCaps®.

When Using This Product
  • do not use more than directed.
Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

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

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.

Section 50570-1 (50570-1)

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.
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan Hydrobromide 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
  • Take only as directed—see Overdose warning.
  • do not exceed 4 doses per 24 hours.
adults and children 12 years of age and over swallow 2 softgels with water every 4 hours
children 4 to under 12 years of age ask a doctor
children under 4 years of age do not use

When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning (Overdose warning)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.

Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Sore Throat Warning (Sore throat warning)

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Inactive Ingredients (Inactive ingredients)

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO



VICKS ® DAYQUIL ®LiquiCaps® ACTIVE INGREDIENTS††

Walgreens

DAYTIME NON-DROWSY

Cold & Flu

Acetaminophen325mg/ ACHES/ FEVER/ SORE THROAT



Dextromethorphan HBr 10mg/ COUGH



Phenylephrine HCl5mg/ NASAL CONGESTION



Relieves aches, fever, sore throat, nasal congestion & cough

Actual Size

24 softgels

†† This product is not manufactured or distributed by



Procter & Gamble, owner of the registered



trademarks Vicks® DayQuil® LiquiCaps®.

When Using This Product (When using this product)
  • do not use more than directed.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy, or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Advanced Ingredient Data


Raw Label Data

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