Sinus Relief, 6ct, Casey's 4good Tm

Sinus Relief, 6ct, Casey's 4good Tm
SPL v2
SPL
SPL Set ID 033837c0-fa68-a38d-e063-6394a90a9832
Route
ORAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Crospovidone Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Starch, Corn Magnesium Stearate Povidone, Unspecified Silicon Dioxide Maltodextrin Cellulose, Microcrystalline Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: 44;527 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

​Drug Facts

Purpose

Purpose Pain reliever/fever reducer Expectorant Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Description

​Drug Facts

Uses

Uses

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
  • headache
  • nasal congestion
  • minor aches and pains
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Warnings

​Warnings

Directions

Directions

  • do not take more than directed
  • adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 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

Allergy Alert

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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
Active Ingredient

Active ingredients (in each caplet)

Acetaminophen 325 mg.

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Other Information

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol,polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments

Questions or comments? 1-877-507-6516 (M-F 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 accidental 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.

Sinus Relief 6ct, Casey's 4good Tm

Compare to the

active ingredients

in Tylenol ® Sinus

Severe*

MULTI-SYMPTOM

Sinus

Relief

Acetaminophen

Pain Reliever

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal Decongestant

Non-Drowsy

Relief of:

Chest Congestion

Nasal Congestion

Sinus Pressure

[Casey's 4good TM logo]

[caplet image]

actual size

6 CAPLETS

Ask A Doctor Before Use If You Have

Ask a doctor before use if you have

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


Structured Label Content

Uses

Uses

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
  • headache
  • nasal congestion
  • minor aches and pains
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Purpose

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Warnings

​Warnings

Directions

Directions

  • do not take more than directed
  • adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 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

Allergy Alert (Allergy alert)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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
Active Ingredient (Active ingredient)

Active ingredients (in each caplet)

Acetaminophen 325 mg.

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Other Information (Other information)

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol,polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments (Questions or comments)

Questions or comments? 1-877-507-6516 (M-F 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 accidental 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.

Sinus Relief 6ct, Casey's 4good Tm (Sinus Relief 6ct, Casey's 4good TM)

Compare to the

active ingredients

in Tylenol ® Sinus

Severe*

MULTI-SYMPTOM

Sinus

Relief

Acetaminophen

Pain Reliever

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal Decongestant

Non-Drowsy

Relief of:

Chest Congestion

Nasal Congestion

Sinus Pressure

[Casey's 4good TM logo]

[caplet image]

actual size

6 CAPLETS

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

Ask a doctor before use if you have

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


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Raw Label Data

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