Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d72d83b8-54ff-4bc4-b66e-bb10d9913f74
Route
ORAL
Published
Effective Date 2015-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Hypromelloses Polyethylene Glycols Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-12-17

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Uses

temporary relief of minor aches and pains associated with    ■ common cold    ■  headache    ■ toothache    ■ muscular aches   ■ backache    ■ arthritis     ■  menstrual cramps   ■  and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 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 use more than directed (see overdose warning)

■ adults and children 12 years and over:
take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

■  do not use more than 10 days unless directed by a doctor

■ children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do Not Use

■ if you are allergic to acetaminophen   ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Active Ingredient

Acetaminophen 500 mg

Inactive Ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.

May contain povidone, and sodium starch glycolate.

Stop Use and Ask A Doctor If

symptoms do not improve pain 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 ■ a rare

sensitivity reaction occurs You may report side effects to 1-888-952-0050

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Ask A Doctor Before Use If You Have

liver disease

Package/label Principal Display Panel

Health A2Z®                    Compare to Tylenol® active ingredient*

See New Warnings Information

Extra Strength

PAIN RELIEF

500mg

Acetaminophen

Pain Reliever-Fever Reducer

CONTAINS NO ASPIRIN

50 Tablets

Health A2Z 235
 

Label 235
      

If You Are Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If You

are taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist  Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses

temporary relief of minor aches and pains associated with    ■ common cold    ■  headache    ■ toothache    ■ muscular aches   ■ backache    ■ arthritis     ■  menstrual cramps   ■  and reduction of fever

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 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 use more than directed (see overdose warning)

■ adults and children 12 years and over:
take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

■  do not use more than 10 days unless directed by a doctor

■ children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do Not Use (Do not use)

■ if you are allergic to acetaminophen   ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Active Ingredient (Active ingredient)

Acetaminophen 500 mg

Inactive Ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.

May contain povidone, and sodium starch glycolate.

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

symptoms do not improve pain 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 ■ a rare

sensitivity reaction occurs You may report side effects to 1-888-952-0050

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

ask a health professional before use

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

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

liver disease

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Health A2Z®                    Compare to Tylenol® active ingredient*

See New Warnings Information

Extra Strength

PAIN RELIEF

500mg

Acetaminophen

Pain Reliever-Fever Reducer

CONTAINS NO ASPIRIN

50 Tablets

Health A2Z 235
 

Label 235
      

If You Are Pregnant Or Breast Feeding, (If you are pregnant or breast-feeding,)

ask a health professional before use.

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

are taking the blood thinning drug warfarin

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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