Target Day Cold & Flu And Night Severe Cold & Flu Tablets

Target Day Cold & Flu And Night Severe Cold & Flu Tablets
SPL v3
SPL
SPL Set ID 08ee56d1-b11d-3e36-e063-6294a90acd5f
Route
ORAL
Published
Effective Date 2023-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Triprolidine (1.25 mg)
Inactive Ingredients
Polyvinyl Alcohol, Unspecified Crospovidone Fd&c Yellow No. 6 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Talc Titanium Dioxide Silicon Dioxide Croscarmellose Sodium Ferric Oxide Yellow Mica Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: N1 Shape: oval Color: red Color: yellow Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4,000 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

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.

Indications and Usage

Uses

Day 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

Night Severe Cold & Flu

temporarily relieves these common cold and flu symptoms:

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

temporarily reduces fever

controls cough to help you get to sleep

Dosage and Administration

Directions

Day Cold & Flu

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Night Severe Cold & Flu

  • do not take more than directed (see Overdose warning)
  • do not take more than 8 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children.

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.

Section 50566-9

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.
Section 50567-7

When using this product

  • do not use more than directed
  • excitability may occur, especially in children (Night Severe Cold & Flu only)
  • marked drowsiness may occur (Night Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only)
  • avoid alcoholic drinks (Night Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only)
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Night Severe Cold & Flu only)
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma (Night Severe Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
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 51727-6

Inactive ingredients Day Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive ingredients Night Severe Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-800-910-6874

Section 53414-9

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

Section 55105-1

Purposes

Day Cold & Flu


Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant



Purposes

Night Severe Cold & Flu


Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

Section 55106-9

Active ingredients (in each caplet)

Day Cold & Flu


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg



Active ingredients (in each caplet)

Night Severe Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg




Structured Label Content

Indications and Usage (34067-9)

Uses

Day 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

Night Severe Cold & Flu

temporarily relieves these common cold and flu symptoms:

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

temporarily reduces fever

controls cough to help you get to sleep

Dosage and Administration (34068-7)

Directions

Day Cold & Flu

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Night Severe Cold & Flu

  • do not take more than directed (see Overdose warning)
  • do not take more than 8 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use
Warnings and Precautions (34071-1)

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4,000 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

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.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children.

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.

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

When using this product

  • do not use more than directed
  • excitability may occur, especially in children (Night Severe Cold & Flu only)
  • marked drowsiness may occur (Night Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only)
  • avoid alcoholic drinks (Night Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only)
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Night Severe Cold & Flu only)
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma (Night Severe Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
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 51727-6 (51727-6)

Inactive ingredients Day Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive ingredients Night Severe Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-910-6874

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Day Cold & Flu


Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant



Purposes

Night Severe Cold & Flu


Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Day Cold & Flu


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg



Active ingredients (in each caplet)

Night Severe Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg




Advanced Ingredient Data


Raw Label Data

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