Daytime Cold & Flu Severe 6ct, Casey's 4good Tm

Daytime Cold & Flu Severe 6ct, Casey's 4good Tm
SPL v2
SPL
SPL Set ID 0334259d-587e-b2d5-e063-6394a90a3e56
Route
ORAL
Published
Effective Date 2023-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Acetaminophen (325 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Talc Polysorbate 80 Polyethylene Glycol, Unspecified Maltodextrin Titanium Dioxide Microcrystalline Cellulose Crospovidone Fd&c Red No. 40 Sodium Starch Glycolate Type A Potato Stearic Acid Silicon Dioxide Starch, Corn Magnesium Stearate Polyvinyl Alcohol, Unspecified Povidone

Identifiers & Packaging

Pill Appearance
Imprint: 44;640 Shape: oval Color: orange Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

​Drug Facts

Purpose

​Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

​Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

​Drug Facts

Uses

Uses

  • temporarily relieves common cold and flu symptoms:
  • minor aches and pains
  • sinus congestion and pressure
  • sore throat
  • fever
  • headache
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • 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
Warnings

​Warnings

Directions

​Directions

  • do not take more than directed
  • do not take more than 8 caplets in 24 hours
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor
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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Drug Facts

​Drug Facts

Alergy Alert

​Alergy 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:This product contains acetaminophen. Severe liver damage may

occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information

Other information

  • each caplet contains: sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Active Ingredients

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments

Questions or comments? 1-877-507-6516 (8AM - 4:30PM CST)

When Using This Product

When using this product do not exceed recommended dosage.

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 rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast Feeding

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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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.

Daytime Cold & Flu, Casey's 4good™ 16ct Pdp/package

Compare to Vicks ®

DayQuil ® VapoCOOL™

SEVERE Cold & Flu +

Congestion
active

ingredients*

SEVERE

DayTime Cold & Flu

Acetaminophen

Pain Reliever / Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Guaifenesin Expectorant

Phenylephrine HCl

Nasal Decongestant

Relieves:

Headache, Cough,

Fever, Minor Aches & Pains,

Sore Throat, Chest Congestion,

Sinus Pressure, Nasal Congestion

Thins & Loosens Mucus

[Casey's 4goodTM logo]

[caplet image]

actual

size

16 CAPLETS

Daytime Cold & Flu Severe 6ct, Casey's 4good Pdp/package

Compare to Vicks ®

DayQuil ® VapoCOOL™

SEVERE Cold & Flu +

Congestion
active

ingredients*

SEVERE

DayTime

Cold & Flu

Acetaminophen

Pain Reliever / Fever Reducer

Phenylephrine HCl

Nasal Decongestant

Dextromethorphan HBr

Cough Suppressant

Guaifenesin Expectorant

Relieves:

Headache, Cough,

Thins & Loosens Mucus,

Fever, Minor Aches & Pains,

Sore Throat, Chest Congestion,

Sinus Pressure, Nasal Congestion

[Casey's 4good TM logo]

[caplet image]

actual

size

6 CAPLETS


Structured Label Content

Uses

Uses

  • temporarily relieves common cold and flu symptoms:
  • minor aches and pains
  • sinus congestion and pressure
  • sore throat
  • fever
  • headache
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • 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
Purpose

​Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings

​Warnings

Directions

​Directions

  • do not take more than directed
  • do not take more than 8 caplets in 24 hours
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor
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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Drug Facts

​Drug Facts

Alergy Alert (Alergy alert)

​Alergy 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)

Liver warning:This product contains acetaminophen. Severe liver damage may

occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information (Other information)

Other information

  • each caplet contains: sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Active Ingredients (Active ingredients)

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Sore Throat Warning (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)

Inactive ingredients

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments (Questions or comments)

Questions or comments? 1-877-507-6516 (8AM - 4:30PM CST)

When Using This Product (When using this product)

When using this product do not exceed recommended dosage.

Stop Use and Ask A Doctor If (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 rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are (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.

Daytime Cold & Flu, Casey's 4good™ 16ct Pdp/package (DayTime Cold & Flu, Casey's 4good™ 16ct - PDP/Package)

Compare to Vicks ®

DayQuil ® VapoCOOL™

SEVERE Cold & Flu +

Congestion
active

ingredients*

SEVERE

DayTime Cold & Flu

Acetaminophen

Pain Reliever / Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Guaifenesin Expectorant

Phenylephrine HCl

Nasal Decongestant

Relieves:

Headache, Cough,

Fever, Minor Aches & Pains,

Sore Throat, Chest Congestion,

Sinus Pressure, Nasal Congestion

Thins & Loosens Mucus

[Casey's 4goodTM logo]

[caplet image]

actual

size

16 CAPLETS

Daytime Cold & Flu Severe 6ct, Casey's 4good Pdp/package (Daytime Cold & Flu Severe 6ct, Casey's 4good PDP/Package)

Compare to Vicks ®

DayQuil ® VapoCOOL™

SEVERE Cold & Flu +

Congestion
active

ingredients*

SEVERE

DayTime

Cold & Flu

Acetaminophen

Pain Reliever / Fever Reducer

Phenylephrine HCl

Nasal Decongestant

Dextromethorphan HBr

Cough Suppressant

Guaifenesin Expectorant

Relieves:

Headache, Cough,

Thins & Loosens Mucus,

Fever, Minor Aches & Pains,

Sore Throat, Chest Congestion,

Sinus Pressure, Nasal Congestion

[Casey's 4good TM logo]

[caplet image]

actual

size

6 CAPLETS


Advanced Ingredient Data


Raw Label Data

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