Acetaminophen Red Ez Tablets

Acetaminophen Red Ez Tablets
SPL v4
SPL
SPL Set ID 181b3148-fa33-c650-e063-6294a90a0de6
Route
ORAL
Published
Effective Date 2024-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone K30 Starch, Corn Sucralose Fd&c Red No. 40 Titanium Dioxide Talc Polyethylene Glycol, Unspecified Lecithin, Soybean Fd&c Yellow No. 6 Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: L;1 Shape: round Color: red Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-09

Description

Acetaminophen USP, 500mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 500mg

Pdp

Uses

 temporarily relieves minor aches and pains due to:



 the common cold  headache

 backache  minor pain of arthritis

 toothache  muscular aches

 premenstrual and menstrual cramps



 temporarily reduces fever

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

Directions

do not take more than directed (see overdose warning)

adults and children 12  take 2 tablets every 6 hours while symptoms last

years and over  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  ask a doctor

12 years

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

Other Information

 store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

 see bottom of the label for lot number and expiration date

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.

Inactive Ingredients

FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Stop Use and Ask A Doctor If

 pain gets worse or lasts 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

Keep Out of Reach of Children

Keep out of reach of children

If Pregnant Or Breast Feeding,

​ask a health professional before use

Ask A Doctor Before Use If You Have

liver disease

Active Ingredient (in Each Coated Tablet)

Acetaminophen USP, 500mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

Pdp (PDP)

Uses

 temporarily relieves minor aches and pains due to:



 the common cold  headache

 backache  minor pain of arthritis

 toothache  muscular aches

 premenstrual and menstrual cramps



 temporarily reduces fever

Purpose

Pain reliever/fever reducer

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

Directions

do not take more than directed (see overdose warning)

adults and children 12  take 2 tablets every 6 hours while symptoms last

years and over  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  ask a doctor

12 years

Do Not Use (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

Other Information (Other information)

 store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

 see bottom of the label for lot number and expiration date

Overdose Warning: (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.

Inactive Ingredients (Inactive ingredients)

FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

 pain gets worse or lasts 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

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

​ask a health professional before use

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Active Ingredient (in Each Coated Tablet) (Active Ingredient (in each coated tablet))

Acetaminophen USP, 500mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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