Greenfield - Pain Relief

Greenfield - Pain Relief
SPL v3
SPL
SPL Set ID d41d2319-8eed-4df9-813c-313497ceb8b4
Route
ORAL
Published
Effective Date 2021-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ328 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-23
Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Use(s)

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 take more than 4000 mg of acetaminophen 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

Directions

■ do not use more than directed (see overdose warning)  

■ adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last

■ Do not take more than 8 caplets in 24 hours unless directed by a doctor 

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

■ children under 12 years: ask a doctor 

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 between 20º-25ºC (68º-77ºF)



  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Active Ingredient(s)

Acetaminophen 500 mg

Inactive Ingredients

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

Pregnancy/breastfeeding

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

Principal Display Panel

Pain Relief
Pain Relief


Ask A Doctor Before Use If

you have liver disease

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



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.

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfarin

Structured Label Content

Use(s)

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 take more than 4000 mg of acetaminophen 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

Directions

■ do not use more than directed (see overdose warning)  

■ adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last

■ Do not take more than 8 caplets in 24 hours unless directed by a doctor 

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

■ children under 12 years: ask a doctor 

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 between 20º-25ºC (68º-77ºF)



  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 500 mg

Inactive Ingredients (Inactive ingredients)

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

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

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

Principal Display Panel

Pain Relief
Pain Relief


Ask A Doctor Before Use If (Ask a doctor before use if)

you have liver disease

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)



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.

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:28.333827 · Updated: 2026-03-14T23:01:25.991637