Daytime Sinus Severe, Lil' Drug Store

Daytime Sinus Severe, Lil' Drug Store
SPL v2
SPL
SPL Set ID e79d92d2-d73c-d44f-e053-2995a90a03d9
Route
ORAL
Published
Effective Date 2022-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;527 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-02

Description

Active ingredients Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Purpose Pain reliever/fever reducer Expectorant Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Description

Active ingredients Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

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
Section 42229-5

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Section 50565-1

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.

Section 50567-7

When using this product do not exceed recommended dosage.

Section 53414-9

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

Stop Use

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.
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
Pdp/package

[caduceus]

*Compare to the Active Ingredients

in Tylenol® SINUS SEVERE

Daytime

Sinus

Severe

Acetaminophen, Guaifenesin, Phenylephrine HCI

Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant

Non-Drowsy Relief of

• Sinus Headache

• Sinus Pressure

• Nasal Congestion

• Mucus & Chest Congestion

[caplet image]

Actual Size

24

Caplets

[Lil' Drug Store logo]

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
Ask A Doctor ...

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
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
Active Ingredients

Active ingredients

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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)

Ask A Doctor Or Pharmacist ...

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
Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

Section 53414-9 (53414-9)

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

Purpose

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Stop Use (Stop use)

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.
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
Pdp/package (PDP/Package)

[caduceus]

*Compare to the Active Ingredients

in Tylenol® SINUS SEVERE

Daytime

Sinus

Severe

Acetaminophen, Guaifenesin, Phenylephrine HCI

Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant

Non-Drowsy Relief of

• Sinus Headache

• Sinus Pressure

• Nasal Congestion

• Mucus & Chest Congestion

[caplet image]

Actual Size

24

Caplets

[Lil' Drug Store logo]

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
Ask A Doctor ... (Ask a doctor ...)

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
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
Active Ingredients (Active ingredients)

Active ingredients

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

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)

Ask A Doctor Or Pharmacist ... (Ask a doctor or pharmacist ...)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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