severe nighttime cold & flu relief

severe nighttime cold & flu relief
SPL v1
SPL
SPL Set ID 484fb43b-8a97-4725-9ea7-aa56fb3610bc
Route
oral
Published
Effective Date 2023-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (650 mg) dextromethorphan (20 mg) doxylamine (12.5 mg) phenylephrine (10 mg)
Inactive Ingredients
anhydrous citric acid edetate disodium fd&c red no. 40 fd&c blue no. 1 glycerin propylene glycol propyl gallate water sodium benzoate sodium chloride sodium citrate, unspecified form sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph final active Since 2023-07-07

Description

Drug Facts Active ingredients (in each 30 mL)


Medication Information

Active Ingredient

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
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 4 to under 12 yrs

ask a doctor

children under 4 years

do not use

Other Information
  • each 30 mL contains: sodium 77 mg
  • Store at room temperature.
  • Do not refrigerate.
Inactive Ingredients

Anhydrous citric acid, disodium edetate, FD&C Red No. 40, FD&C Blue No. 1, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum.

Description

Drug Facts Active ingredients (in each 30 mL)

Questions?

1-866-467-2748

Section 42229-5

Drug Facts

Active ingredients (in each 30 mL)

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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.
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

If a skin reaction occurs, stop use and seek medical help right away

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, and 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.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet
Principal Display Panel 354ml Bottle Label

*Compare to the active ingredients inVICKS® NyQuil™ Severe Cold & Flu

NDC 55319-681-08

Severe

NightTime

Cold & Flu

Relief

Acetaminophen- Pain reliever/Fever reducer

Phenylephrine HCl – Nasal decongestant

Doxylamine Succinate - Antihistamine

Dextromethorphan HBr – Cough suppressant

  • Headache, Fever, Sore Throat,

    Minor Aches & Pains

  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Mixed Berry Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Active Ingredient (55106-9)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
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 4 to under 12 yrs

ask a doctor

children under 4 years

do not use

Other Information (Other information)
  • each 30 mL contains: sodium 77 mg
  • Store at room temperature.
  • Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, disodium edetate, FD&C Red No. 40, FD&C Blue No. 1, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum.

Questions?

1-866-467-2748

Section 42229-5 (42229-5)

Drug Facts

Active ingredients (in each 30 mL)

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.

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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.
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:

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

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, and 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.

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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet
Principal Display Panel 354ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354mL Bottle Label)

*Compare to the active ingredients inVICKS® NyQuil™ Severe Cold & Flu

NDC 55319-681-08

Severe

NightTime

Cold & Flu

Relief

Acetaminophen- Pain reliever/Fever reducer

Phenylephrine HCl – Nasal decongestant

Doxylamine Succinate - Antihistamine

Dextromethorphan HBr – Cough suppressant

  • Headache, Fever, Sore Throat,

    Minor Aches & Pains

  • Nasal Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Mixed Berry 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)