Daytime Severe Cold & Flu Relief Honey Flavor

Daytime Severe Cold & Flu Relief Honey Flavor
SPL v1
SPL
SPL Set ID f7abdad5-43ed-425b-bbe6-ec1f8f18ca1c
Route
ORAL
Published
Effective Date 2023-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Guaifenesin (200 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Yellow No. 10 Edetate Disodium Fd&c Green No. 3 Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-07-05

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Drug Facts

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

Drug Facts

Section 50565-1

Keep out of reach of children.

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 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 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

  • adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hrs, 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 9 mg
  • Store at room temperature
  • Do not refrigerate.
Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients

citric acid, D&C Yellow No. 10, edetate disodium, FD&C Green No. 3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

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 lasts more than 5 days (children) 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.
Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 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)
  • persists or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 354 Ml Bottle Label

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

NDC 55319-061-08

DayTime

Severe

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Guaifenesin – Expectorant

Phenylephrine HCl - Nasal decongestant

Dextromethorphan HBr – Cough suppressant

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Chest Congestion, Thins & Loosens Mucus
  • Nasal Congestion, Sinus Pressure
  • Cough

Honey Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


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)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 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

  • adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hrs, 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 9 mg
  • Store at room temperature
  • Do not refrigerate.
Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients (Inactive ingredients)

citric acid, D&C Yellow No. 10, edetate disodium, FD&C Green No. 3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

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 lasts more than 5 days (children) 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.
Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 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)
  • persists or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 354 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label)

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

NDC 55319-061-08

DayTime

Severe

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Guaifenesin – Expectorant

Phenylephrine HCl - Nasal decongestant

Dextromethorphan HBr – Cough suppressant

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Chest Congestion, Thins & Loosens Mucus
  • Nasal Congestion, Sinus Pressure
  • Cough

Honey Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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