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.

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 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 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

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 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 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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