Redicare Non-aspirin 500mg

Redicare Non-aspirin 500mg
SPL v2
SPL
SPL Set ID 2f229898-1777-732c-e063-6394a90a76bc
Route
ORAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Povidone Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ;011 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-27

Description

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500mg

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

Section 51945-4

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

Directions:

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

Children under 12 years: ask a doctor

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.

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

■ store between 20°-25°C (68°-77°F)

■ do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients:

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments?

Call 1-866-561-5650 Monday to Friday 9am-5pm EST

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Tablet)

Acetaminophen 500mg

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


Structured Label Content

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

Section 51945-4 (51945-4)

Purpose

Pain reliever/fever reducer

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

Directions:

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

Children under 12 years: ask a doctor

Allergy Alert: (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.

Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

Overdose Warning: (Overdose warning:)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

■ store between 20°-25°C (68°-77°F)

■ do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients:

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or Comments?)

Call 1-866-561-5650 Monday to Friday 9am-5pm EST

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

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

ask a health professional before use.

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

Acetaminophen 500mg

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

liver disease

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

you are taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)