Aramark Extra Strength Acetaminophen

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Microcrystalline Cellulose Povidone Sodium Starch Glycolate Type A Corn Starch, Corn Stearic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-05-14

Medication Information

Warnings and Precautions

Warnings:

Allergy Alert: Acetaminophen may cause a severe skin

reactions.

Symptoms may include:

• Skin reddening •Blisters •Rash

• If a skin reaction occurs, stop use and seek medical

right away.

Liver Warning: This product contains an

acetaminophen. Severe liver damage may occur if you

take:

• more than 8 tablets in 24 hours, which is the

maximum daily amount

• 3 or more alcoholic drinks every day while using this

product

• take more or for a longer time than directed

Indications and Usage

Uses:

Temporarily Relieves minor aches and pains

due to:

• Headache, toothaches, menstrual cramps,

the common cold,

• muscular aches, minor pain of arthritis

Temporarily reduces fever

Dosage and Administration

Directions:

• do not take more than directed

• adults and children 12 years and over: take 2

tablets every 4 to 6 hours as needed

• do not exceed 8 tablets in 24 hours, unless

directed by a doctor

• Children under 12 years: Do not use this product

Description

Drug Facts 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 50566-9

Stop use and ask a doctor if:

• pain gets worse lasts more than 10 days

• feel faint

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• redness or swelling is present in the painful area

• any new symptoms occur

Section 50567-7

When using this product:

• take with food or milk if stomach upset occurs

• the risk of heart attack or stroke may increase if

you use more than directed or for longer than

directed

Section 50568-5

Ask a doctor or pharmacist before use if you are:

• under a doctor’s care for any serious condition

• 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:

• if you have ever had an allergic reaction to any

other pain

• reliever/fever reducer

• right before or after heart surgery

• if you have ever had an allergic reaction to this

product or any of its ingredients

Section 51727-6

Inactive Ingredients:

Microcrystalline Cellulose, Povidone, Sodium Starch

Glycolate, Starch, Stearic Acid

Section 53414-9

If pregnant or breast-feeding, ask a health

professional before use.

Section 55105-1

Purpose

Acetaminophen ...................Pain Reliever/Fever Reducer

Section 55106-9

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Section 60561-8

Other information:

read all warnings and directions before use. Keep

carton. Store at 20-25°C (68-77°F) avoid excessive

heat above 40°C (104°F)

Package Labeling

aramark

100 TABLETS Part # 90433B

PER BOX

Extra Strength

Acetaminophen

Pain Reliever/Fever Reducer

Temporary relief of minor aches and

pains associated with a cold,

headache, tootache, muscular aches,

and for the reduction of fever

Compare active ingredient to:

Extra Strength Tylenol^®

Registered Trademark of Johnson & Johnson

MANUFACTURED FOR:

Aramark

Lenexa, KS 66219

866-362-2691

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

250 Tablet Box

2-Tablet Packet

res

Structured Label Content

Indications and Usage (34067-9)

Uses:

Temporarily Relieves minor aches and pains

due to:

• Headache, toothaches, menstrual cramps,

the common cold,

• muscular aches, minor pain of arthritis

Temporarily reduces fever

Dosage and Administration (34068-7)

Directions:

• do not take more than directed

• adults and children 12 years and over: take 2

tablets every 4 to 6 hours as needed

• do not exceed 8 tablets in 24 hours, unless

directed by a doctor

• Children under 12 years: Do not use this product

Warnings and Precautions (34071-1)

Warnings:

Allergy Alert: Acetaminophen may cause a severe skin

reactions.

Symptoms may include:

• Skin reddening •Blisters •Rash

• If a skin reaction occurs, stop use and seek medical

right away.

Liver Warning: This product contains an

acetaminophen. Severe liver damage may occur if you

take:

• more than 8 tablets in 24 hours, which is the

maximum daily amount

• 3 or more alcoholic drinks every day while using this

product

• take more or for a longer time than directed

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 50566-9 (50566-9)

Stop use and ask a doctor if:

• pain gets worse lasts more than 10 days

• feel faint

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• redness or swelling is present in the painful area

• any new symptoms occur

Section 50567-7 (50567-7)

When using this product:

• take with food or milk if stomach upset occurs

• the risk of heart attack or stroke may increase if

you use more than directed or for longer than

directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are:

• under a doctor’s care for any serious condition

• 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:

• if you have ever had an allergic reaction to any

other pain

• reliever/fever reducer

• right before or after heart surgery

• if you have ever had an allergic reaction to this

product or any of its ingredients

Section 51727-6 (51727-6)

Inactive Ingredients:

Microcrystalline Cellulose, Povidone, Sodium Starch

Glycolate, Starch, Stearic Acid

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health

professional before use.

Section 55105-1 (55105-1)

Purpose

Acetaminophen ...................Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Section 60561-8 (60561-8)

Other information:

read all warnings and directions before use. Keep

carton. Store at 20-25°C (68-77°F) avoid excessive

heat above 40°C (104°F)

Package Labeling

aramark

100 TABLETS Part # 90433B

PER BOX

Extra Strength

Acetaminophen

Pain Reliever/Fever Reducer

Temporary relief of minor aches and

pains associated with a cold,

headache, tootache, muscular aches,

and for the reduction of fever

Compare active ingredient to:

Extra Strength Tylenol^®

Registered Trademark of Johnson & Johnson

MANUFACTURED FOR:

Aramark

Lenexa, KS 66219

866-362-2691

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

250 Tablet Box

2-Tablet Packet

res

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Temporarily Relieves minor aches and pains due to: • Headache, toothaches, menstrual cramps, the common cold, • muscular aches, minor pain of arthritis Temporarily reduces fever", "34068-7": "Directions: • do not take more than directed • adults and children 12 years and over: take 2 tablets every 4 to 6 hours as needed • do not exceed 8 tablets in 24 hours, unless directed by a doctor • Children under 12 years: Do not use this product", "34071-1": "Warnings: Allergy Alert: Acetaminophen may cause a severe skin reactions. Symptoms may include: • Skin reddening •Blisters •Rash • If a skin reaction occurs, stop use and seek medical right away. Liver Warning: This product contains an acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed", "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.", "50566-9": "Stop use and ask a doctor if: • pain gets worse lasts more than 10 days • feel faint • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms occur", "50567-7": "When using this product: • take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed", "50568-5": "Ask a doctor or pharmacist before use if you are: • under a doctor’s care for any serious condition • taking the blood thinning drug Warfarin", "50569-3": "Ask a doctor before use if: • you have liver disease", "50570-1": "Do not use: • if you have ever had an allergic reaction to any other pain • reliever/fever reducer • right before or after heart surgery • if you have ever had an allergic reaction to this product or any of its ingredients", "51727-6": "Inactive Ingredients: Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Acetaminophen ...................Pain Reliever/Fever Reducer", "55106-9": "Drug Facts Active Ingredient (in each tablet) Acetaminophen 500 mg", "60561-8": "Other information: read all warnings and directions before use. Keep carton. Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)", "Package Labeling": "aramark 100 TABLETS Part # 90433B PER BOX Extra Strength Acetaminophen Pain Reliever/Fever Reducer Temporary relief of minor aches and pains associated with a cold, headache, tootache, muscular aches, and for the reduction of fever Compare active ingredient to: Extra Strength Tylenol ® Registered Trademark of Johnson & Johnson MANUFACTURED FOR: Aramark Lenexa, KS 66219 866-362-2691 aramarkuniform.com Retain carton for complete product information 100 Tablet Box 250 Tablet Box 2-Tablet Packet res"}

Aramark Extra Strength Acetaminophen

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information