mckesson sinus pain and pressure relief

mckesson sinus pain and pressure relief
SPL v3
SPL
SPL Set ID e0cbb213-4f4f-4045-e053-2a95a90a2a18
Route
oral
Published
Effective Date 2022-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenylephrine (5 mg) acetaminophen (500 mg)
Inactive Ingredients
povidone hypromellose, unspecified cellulose, microcrystalline polyethylene glycol, unspecified stearic acid starch, corn crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ;261 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-09-01

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 of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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.

Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Indications and Usage

Uses

temporarily relieves these common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

Dosage and Administration

Directions

  • do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Over dose warning:

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

  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms appear

These could be signs of a serious condition.

Section 50567-7

When using this product do not exceed recommended dosage.

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland
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.
  • for more than 10 days unless directed by a doctor
Section 51727-6

Inactive imgredients

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

Section 51945-4

McKesson

Sinus Pain and Pressure Relief

Acetaminophen 500 mg | Phenylephrine HCl 5 mg

NDC 68599-4751-3

This Package is for Households without Young Children.

Non-aspirin pain relief and pseudoephrine-free sinus decongestant.

Section 53413-1

Questions or comments? C all 1-800-777-4908

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 60561-8

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity

Structured Label Content

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 of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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.

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Indications and Usage (34067-9)

Uses

temporarily relieves these common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

  • do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Over dose warning:

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

  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms appear

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist 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
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland
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.
  • for more than 10 days unless directed by a doctor
Section 51727-6 (51727-6)

Inactive imgredients

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

Section 51945-4 (51945-4)

McKesson

Sinus Pain and Pressure Relief

Acetaminophen 500 mg | Phenylephrine HCl 5 mg

NDC 68599-4751-3

This Package is for Households without Young Children.

Non-aspirin pain relief and pseudoephrine-free sinus decongestant.

Section 53413-1 (53413-1)

Questions or comments? C all 1-800-777-4908

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 60561-8 (60561-8)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)