Pain And Sinus Reliever

Pain And Sinus Reliever
SPL v1
SPL
SPL Set ID 249373c6-f56f-4bd3-9cef-98b7ee73457d
Route
ORAL
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ261 Shape: round Color: white Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-09

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

temporarily relieves:

  • headache
  • sinus pain
  • nasal and sinus congestion
  • minor aches and pains
  • fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland.

Section 53414-9

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

Section 55105-1
Active ingredient (In Each Tablet) Purpose
Acetaminophen 500 mg pain reliever/fever reducer
Phenylephrine 5 mg nasal decongestant
Directions

Adults and children 12 years of age and older:

  • Take 2 tablets every 6 hours
  • do not exceed 8 tablets in 24 hours

Children under 12 years of age: Ask a doctor

Do Not Use
  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product
  • for more than 3 days for fever unless directed by a doctor
  • with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist
  • for more than 10 days for pain unless directed by a doctor
Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

Liver Warning

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

  • more than 8 tablets or 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen (prescription or nonprescription)
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning

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

Other Information
  • store at room temperature between 20-25 °C (68-77° F)
  • do not use if packet is opened or torn
Inactive Ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Principal Display Panel 250 Tablet Packet Box

Product #1194

Pain & Sinus

Reliever

Active ingredient:

Acetaminophen

Phenylephrine

Pain Reliever/Nasal Decongestant

  • Formulated for relief from sinus pressure

    and nasal congestion
  • Aspirin free non-drowsy formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2021 standards.

They are sealed in tamper evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet


Structured Label Content

Use

temporarily relieves:

  • headache
  • sinus pain
  • nasal and sinus congestion
  • minor aches and pains
  • fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredient (In Each Tablet) Purpose
Acetaminophen 500 mg pain reliever/fever reducer
Phenylephrine 5 mg nasal decongestant
Directions

Adults and children 12 years of age and older:

  • Take 2 tablets every 6 hours
  • do not exceed 8 tablets in 24 hours

Children under 12 years of age: Ask a doctor

Do Not Use (Do not use)
  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product
  • for more than 3 days for fever unless directed by a doctor
  • with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist
  • for more than 10 days for pain unless directed by a doctor
Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

Liver Warning

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

  • more than 8 tablets or 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen (prescription or nonprescription)
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning (Overdose warning)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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)
  • store at room temperature between 20-25 °C (68-77° F)
  • do not use if packet is opened or torn
Inactive Ingredients (Inactive ingredients)

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Principal Display Panel 250 Tablet Packet Box (PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box)

Product #1194

Pain & Sinus

Reliever

Active ingredient:

Acetaminophen

Phenylephrine

Pain Reliever/Nasal Decongestant

  • Formulated for relief from sinus pressure

    and nasal congestion
  • Aspirin free non-drowsy formula

These quality comfort tablets are formulated and packaged for use in the

workplace and meet ANSI Z308.1-2021 standards.

They are sealed in tamper evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet


Advanced Ingredient Data


Raw Label Data

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