819r Sinus Pain And Pressure Unifirst Mf/mfp Oc

819r Sinus Pain And Pressure Unifirst Mf/mfp Oc
SPL v21
SPL
SPL Set ID f196f2c5-a100-42b1-bd01-0327b223838e
Route
ORAL
Published
Effective Date 2023-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ;261 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-30

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.

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 ingredients

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

Section 53413-1

Questions or comments? 1-800-634-7680

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 55106-9

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

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

Otis Clapp Mygrex Label

Otis Clapp

Quality and Integrity Since 1840

MYGREX ™

Pain Reliever-Decongestant

Advanced Relief

For Sinus/Headaches

See Warnings and Directions on Side Panel

This package is for Households without Young Children.

Acetaminophen 500 mg • Aches & Fever

Phenylephrine HCl 5 mg • Nasal Decongestant

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 Tablets (150 PACKETS OF 2)

Medi First Sinus Pain and Pressure Label

Medi-First ®

Sinus Pain and Pressure

Aches & Fever • Acetaminophen 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children.

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2)

Medi First Plus Sinus Pain and Pressure Label

100 Tablets

(505 x 2's)

Medi First ® Plus

Sinus Pain and Pressure

Aches & Fever • Acetaminophen 500mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children.

Sinus Pain Relief

Tamper Evident

Unit Dose Packet


Structured Label Content

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

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.

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 ingredients

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

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

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 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

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

Otis Clapp Mygrex Label

Otis Clapp

Quality and Integrity Since 1840

MYGREX ™

Pain Reliever-Decongestant

Advanced Relief

For Sinus/Headaches

See Warnings and Directions on Side Panel

This package is for Households without Young Children.

Acetaminophen 500 mg • Aches & Fever

Phenylephrine HCl 5 mg • Nasal Decongestant

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 Tablets (150 PACKETS OF 2)

Medi First Sinus Pain and Pressure Label (Medi-First Sinus Pain and Pressure Label)

Medi-First ®

Sinus Pain and Pressure

Aches & Fever • Acetaminophen 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children.

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2)

Medi First Plus Sinus Pain and Pressure Label (Medi-First Plus Sinus Pain and Pressure Label)

100 Tablets

(505 x 2's)

Medi First ® Plus

Sinus Pain and Pressure

Aches & Fever • Acetaminophen 500mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children.

Sinus Pain Relief

Tamper Evident

Unit Dose Packet


Advanced Ingredient Data


Raw Label Data

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