Target Daytime Cold & Flu And Nighttime Severe Cold & Flu Liquid

Target Daytime Cold & Flu And Nighttime Severe Cold & Flu Liquid
SPL v3
SPL
SPL Set ID 0fc523ce-55a7-6384-e063-6394a90aad3f
Route
ORAL
Published
Effective Date 2022-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg) Triprolidine (2.5 mg) Guaifenesin (400 mg)
Inactive Ingredients
Glycerin Sodium Citrate Anhydrous Citric Acid Ascorbic Acid Edetate Disodium Fd&c Blue No. 1 Propylene Glycol Sodium Benzoate Sorbitol Sucralose Water Xanthan Gum Propyl Gallate Fd&c Red No. 40 Trisodium Citrate Dihydrate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Daytime Cold & Flu


Medication Information

Description

Daytime Cold & Flu

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

Purposes

Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Nighttime Severe Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

Section 55106-9

Daytime Cold & Flu

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Nighttime Severe Cold and Flu

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Triprolidine HCl 2.5 mg

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.
Drug Facts

Daytime Cold & Flu

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.

Liver Warning

Daytime Cold & Flu

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Nighttime Severe Cold & Flu

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Overdose Warning

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

Daytime Cold & Flu

  • each 20 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Nighttime Severe Cold and Flu

  • each 20 mL contains: sodium 17 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Daytime Cold & Flu

temporarily relieves these common cold and flu symptoms:

  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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.

Inactive Ingredients

Daytime Cold & Flu

anhydrous citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Nighttime Severe Cold and Flu

anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

Call 1-800-910-6874

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Severe Cold & Flu only)
  • marked drowsiness may occur (Nightshift Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Severe Cold & Flu only)
  • avoid alcoholic drinks (Nightshift Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Severe Cold & Flu only)
Nighttime Severe Cold & Flu

temporarily relieves these common cold and flu symptoms:

  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • sinus congestion and pressure
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever

temporarily reduces fever

controls cough to help you get to sleep

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • 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 fever, rash, or headache that lasts.

These could be signs of a serious condition.

Nighttime Severe Cold and Flu

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Ask A Doctor Before Use If You Have

Daytime Cold & Flu

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Nighttime Severe Cold & Flu

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel Kit Carton

Ask A Doctor Or Pharmacist Before Use If You Are

Daytime Cold & Flu

  • taking the blood thinning drug warfarin

Nighttime Severe Cold and Flu

  • ​taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

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)

Purposes

Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Nighttime Severe Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

Section 55106-9 (55106-9)

Daytime Cold & Flu

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Nighttime Severe Cold and Flu

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Triprolidine HCl 2.5 mg

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.
Drug Facts

Daytime Cold & Flu

Allergy Alert (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.

Liver Warning (Liver warning)

Daytime Cold & Flu

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Nighttime Severe Cold & Flu

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Overdose Warning (Overdose warning)

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)

Daytime Cold & Flu

  • each 20 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Nighttime Severe Cold and Flu

  • each 20 mL contains: sodium 17 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Daytime Cold & Flu

temporarily relieves these common cold and flu symptoms:

  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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.

Inactive Ingredients (Inactive ingredients)

Daytime Cold & Flu

anhydrous citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Nighttime Severe Cold and Flu

anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Severe Cold & Flu only)
  • marked drowsiness may occur (Nightshift Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Severe Cold & Flu only)
  • avoid alcoholic drinks (Nightshift Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Severe Cold & Flu only)
Nighttime Severe Cold & Flu

temporarily relieves these common cold and flu symptoms:

  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • sinus congestion and pressure
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever

temporarily reduces fever

controls cough to help you get to sleep

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • 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 fever, rash, or headache that lasts.

These could be signs of a serious condition.

Nighttime Severe Cold and Flu

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Daytime Cold & Flu

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Nighttime Severe Cold & Flu

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

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

Daytime Cold & Flu

  • taking the blood thinning drug warfarin

Nighttime Severe Cold and Flu

  • ​taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)