SPL v4
SPL
SPL Set ID c08f5ac3-b2cf-44e8-9e38-259addf61abd
Route
ORAL
Published
Effective Date 2019-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 1)
Inactive Ingredients
Starch, Corn Cellulose, Microcrystalline Povidone Sodium Starch Glycolate Type A Potato Stearic Acid Hypromellose, Unspecified Maltodextrin Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Imprint: FR1 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-15

Description

ACTIVE INGREDIENT IN EACH TABLET- Acetaminophen 500 mg


Medication Information

Warnings and Precautions

Warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • you have 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.

Do not use: • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

When using this product do not exceed recommended dose.

Ask a doctor before use if you have liver disease

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

Stop use and ask a doctor if: • pain or fever persists or gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • new symptoms occur • redness or swelling is present. These could be signs of a serious condition.

Indications and Usage

Uses: temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor arthritis pain

Temporarily reduces fever

Dosage and Administration

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: consult a doctor

Description

ACTIVE INGREDIENT IN EACH TABLET- Acetaminophen 500 mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive Ingredients: corn starch, hydroxypropyl methylcelluslose*, maltodextrin*, polyethylen glycol*, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

*contains one or more of these ingredients

Section 51945-4

Extra Strength

PAIN RELIEVER

Acetaminophen

Pain Reliever / Fever Reducer

COMPARE TO THE ACTIVE INGREDIENTS IN

TYLENOL ® EXTRA STRENGTH*

6 TABLETS

Section 53414-9

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

Section 55105-1

Analgesic, Antipyretic (fever reducer)

Section 55106-9

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg


Structured Label Content

Indications and Usage (34067-9)

Uses: temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor arthritis pain

Temporarily reduces fever

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: consult a doctor

Warnings and Precautions (34071-1)

Warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • you have 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.

Do not use: • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

When using this product do not exceed recommended dose.

Ask a doctor before use if you have liver disease

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

Stop use and ask a doctor if: • pain or fever persists or gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • new symptoms occur • redness or swelling is present. These could be signs of a serious condition.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive Ingredients: corn starch, hydroxypropyl methylcelluslose*, maltodextrin*, polyethylen glycol*, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

*contains one or more of these ingredients

Section 51945-4 (51945-4)

Extra Strength

PAIN RELIEVER

Acetaminophen

Pain Reliever / Fever Reducer

COMPARE TO THE ACTIVE INGREDIENTS IN

TYLENOL ® EXTRA STRENGTH*

6 TABLETS

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Analgesic, Antipyretic (fever reducer)

Section 55106-9 (55106-9)

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg


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