Day Time Cold & Flu Multi-symptom Relief

Day Time Cold & Flu Multi-symptom Relief
SPL v7
SPL
SPL Set ID 8aea46b0-d317-42e6-97d3-1cae8d27c818
Route
ORAL
Published
Effective Date 2020-07-02
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 Yellow No. 6 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 512 Shape: capsule Color: orange Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-02

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

If taking Daytime and Nighttime softgels carefully read each label to insure 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
Allergy Alert:

acetaminophen may cause severe skin reactions. Symptoms may include: 

  • skin reddening
  • blisters
  • rash
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
  • this product does not contain phenylpropanolamine
Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

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.

Questions Or Comments?

1-888-333-9792

Principal Display Panel

COMPARE TO ACTIVE INGREDIENTS IN

VICKS ® DAYQUIL ®*

DAY TIME

COLD & FLU MULTI-SYMPTOM RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl

Liquid filled capsules

When Using This Product
  • do not use more than directed.
Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • pain, nasal congestion or cough gets worse or last 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.

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

If taking Daytime and Nighttime softgels carefully read each label to insure 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
Allergy Alert: (Allergy alert:)

acetaminophen may cause severe skin reactions. Symptoms may include: 

  • skin reddening
  • blisters
  • rash
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
  • this product does not contain phenylpropanolamine
Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

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.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO ACTIVE INGREDIENTS IN

VICKS ® DAYQUIL ®*

DAY TIME

COLD & FLU MULTI-SYMPTOM RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl

Liquid filled capsules

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
  • pain, nasal congestion or cough gets worse or last 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.

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

All Sections (JSON)