unishield extra strength non-aspirin

unishield extra strength non-aspirin
SPL v6
SPL
SPL Set ID ba0ec1eb-db85-6a7f-e053-2995a90aafe5
Route
oral
Published
Effective Date 2021-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
stearic acid starch, corn sodium starch glycolate type a potato povidone, unspecified povidone cellulose, microcrystalline hypromelloses maltodextrin polyethylene glycol, unspecified titanium dioxide hypromellose, unspecified povidone k30

Identifiers & Packaging

Pill Appearance
Imprint: G552 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-10-01 Until 2023-11-01

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 in 24 hours, which is the maximum daily amount

■ 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 ingredient (in each tablet)

Acetaminophen 500 mg.

Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

temporarily reduces fever

Dosage and Administration

Directions

do not use more than directed (see overdose warning)

Adults and children 12 years and over

■ take 2 tablets every 6 hours while symptoms last.

■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not use for more than 10 days unless directed by a doctor

Children under 12 years Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Overdose 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 using and ask a doctor if

■ pain gets worse or lasts more than for more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

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

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 allergic to acetaminophen or any of the inactive ingredients in this product

Section 51727-6

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid*, titanium dioxide*.

* may contain

Section 53413-1

Questions or comments? 800-480-5855

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

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

Unishield Extra Strength Non Aspirin

Unishield

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

100 Tablets/2Tablets Per Packet

Acetaminophen 500 mg

Pull To Open

This Package is for Households Without Young Children.

• Relieves headaches, backaches, muscular aches and more

• Temporarily relieves fever

Compare active ingredients to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

Unishield Extra Strength Non Aspirin Label

Unishield

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

100 Tablets/2Tablets Per Packet

Acetaminophen 500 mg

Pull To Open

This Package is for Households Without Young Children.

• Relieves headaches, backaches, muscular aches and more

• Temporarily relieves fever

Compare active ingredients to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets


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 in 24 hours, which is the maximum daily amount

■ 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 ingredient (in each tablet)

Acetaminophen 500 mg.

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

do not use more than directed (see overdose warning)

Adults and children 12 years and over

■ take 2 tablets every 6 hours while symptoms last.

■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not use for more than 10 days unless directed by a doctor

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.

Overdose 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 using and ask a doctor if

■ pain gets worse or lasts more than for more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

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

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 allergic to acetaminophen or any of the inactive ingredients in this product

Section 51727-6 (51727-6)

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid*, titanium dioxide*.

* may contain

Section 53413-1 (53413-1)

Questions or comments? 800-480-5855

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

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

Unishield Extra Strength Non Aspirin (Unishield Extra Strength Non-Aspirin)

Unishield

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

100 Tablets/2Tablets Per Packet

Acetaminophen 500 mg

Pull To Open

This Package is for Households Without Young Children.

• Relieves headaches, backaches, muscular aches and more

• Temporarily relieves fever

Compare active ingredients to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

Unishield Extra Strength Non Aspirin Label (Unishield Extra Strength Non-Aspirin Label)

Unishield

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

100 Tablets/2Tablets Per Packet

Acetaminophen 500 mg

Pull To Open

This Package is for Households Without Young Children.

• Relieves headaches, backaches, muscular aches and more

• Temporarily relieves fever

Compare active ingredients to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets


Advanced Ingredient Data


Raw Label Data

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