easyfast

easyfast
SPL v2
SPL
SPL Set ID 4c2b5c18-8a8c-45ce-8860-335c8549ee88
Route
oral
Published
Effective Date 2023-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
microcrystalline cellulose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-04-01

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg


Medication Information

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 capsules 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.

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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

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 • new symptoms occur • redness or swelling is present • symptoms do not improve

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

Uses

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

• temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

• Adults and children12 years and older: • take 1 capsule every 3-4 hours, or 2 capsules every 6 hours, while symptoms persist • do not exceed 8 capsules in 24 hours • or as directed by a doctor.

• Children under 12 years: ask a doctor

Other Information

• store between 20-25º C (68-77º F) • do not use if foil pouch is open or broken

Inactive Ingredients

Micro Crystalline Cellulose (MCC)

Description

Acetaminophen 500 mg

Section 42229-5

2 delayed-release capsules

Manufactured for: Easyfast Supplements

Brooklyn, NY 11229

Made in the USA

Please email us:

[email protected]

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Packaging

Drug Facts

Questions Or Comments?

+1-516-399-0613

You may also report serious side effects to this phone  number.  Monday-Friday, 9:00 am-4:30 pm

Active Ingredient (in Each Capsule)

Acetaminophen 500 mg


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 capsules 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.

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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

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 • new symptoms occur • redness or swelling is present • symptoms do not improve

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

Uses

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

• temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

• Adults and children12 years and older: • take 1 capsule every 3-4 hours, or 2 capsules every 6 hours, while symptoms persist • do not exceed 8 capsules in 24 hours • or as directed by a doctor.

• Children under 12 years: ask a doctor

Other Information (Other information)

• store between 20-25º C (68-77º F) • do not use if foil pouch is open or broken

Inactive Ingredients (Inactive ingredients)

Micro Crystalline Cellulose (MCC)

Section 42229-5 (42229-5)

2 delayed-release capsules

Manufactured for: Easyfast Supplements

Brooklyn, NY 11229

Made in the USA

Please email us:

[email protected]

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

+1-516-399-0613

You may also report serious side effects to this phone  number.  Monday-Friday, 9:00 am-4:30 pm

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)