Acetaminophen 500 mg Tablet

Acetaminophen (Paracetamol) 500‑mg-Tablet

Therapeutic Class: Pain Management

Dosage Forms: Tablets

Brand Name: Acetaminophen 500 mg Tablet™

Best Acetaminophen 500 mg Tablet manufacturer, supplier & exporter in India.
Our Certifications
WHO
WHO
PPB KENYA
PPB KENYA
MOH MYANMAR
MOH MYANMAR
NAFDAC NIGERIA
NAFDAC NIGERIA
MOH GHANA
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MOH COMBODIA
MOH COMBODIA
FDA JORDAN
FDA JORDAN

How it works?

Uses of Acetaminophen 500 mg Tablet

How Acetaminophen 500 mg Tablet Works (Pharmacodynamics)

  • Category: Analgesic (pain reliever) and antipyretic (fever reducer)
  • Mechanism:
    • Blocks an enzyme called cyclooxygenase (COX), which helps produce prostaglandins (chemicals that cause pain and fever)
    • Works mainly in the brain, not in the rest of the body
    • That’s why it reduces pain and fever but doesn’t help much with inflammation

Precautions of Acetaminophen 500 mg Tablet

Important Precautions While Taking Acetaminophen 500 mg Tablet

Avoid Taking Multiple Products

  • Don’t take more than one medicine that contains acetaminophen at the same time.

Risk of Metabolic Acidosis (HAGMA)

  • Rare cases of a serious condition called pyroglutamic acidosis have been reported.
  • This can happen in people with:
    • Kidney problems
    • Sepsis (severe infection)
    • Malnutrition
    • Alcoholism
  • Risk increases if acetaminophen is taken for a long time or with flucloxacillin.
  • If suspected, stop acetaminophen and monitor closely.

Liver & Kidney Health

  • People with liver or kidney disease should talk to a doctor before using acetaminophen.
  • Taking too much can damage the liver—never exceed the recommended dose.

When to See a Doctor

  • If headaches don’t go away
  • If you have mild arthritis and need pain relief daily
  • If symptoms persist or worsen

Glutathione Deficiency

  • Use with caution if you have conditions that lower glutathione (a natural body chemical), such as:
    • Metabolic disorders
    • Malnutrition
    • Chronic illness
  • These conditions may increase the risk of acidosis.

Pregnancy &  Breastfeeding

Pregnancy

  • Studies show no major risks to the baby when acetaminophen is used during pregnancy.
  • Some research on child development is inconclusive.
  • If needed, use the lowest dose for the shortest time.

Breastfeeding

  • Small amounts may pass into breast milk, but not enough to harm the baby.
  • Safe to use while breastfeeding at normal doses.

Dosages administration of Acetaminophen 500 mg Tablet

Dosage Instructions of Acetaminophen 500 mg Tablet

Adults, Elderly & Children (16+ years)

  • Dose: 1–2 tablets
  • Frequency: Up to 4 times daily as needed
  • Maximum: No more than 8 tablets in 24 hours
  • Interval: At least 4 hours between doses

Children (10–15 years)

  • Dose: 1 tablet
  • Frequency: Up to 4 times daily
  • Limit: Do not use for more than 3 days without medical advice.
  • Interval: Minimum 4 hours between doses.

Not Suitable For

  • Children under 10 years of age.

Directions for Use

  • Route: Oral only.
  • Form: Swallow tablets with water.
  • Do not exceed the recommended dose or frequency.

Side effects of Acetaminophen 500 mg Tablet

Side Effects of Acetaminophen 500 mg Tablet

Frequency Classification

  • Very common: ≥1 in 10
  • Common: ≥1 in 100 to <1 in 10
  • Uncommon: ≥1 in 1,000 to <1 in 100
  • Rare: ≥1 in 10,000 to <1 in 1,000
  • Very rare: <1 in 10,000
  • Not known: Cannot be estimated from available data

Blood & Lymphatic Disorders

  • Very rare:
    • Agranulocytosis (low white blood cells)
    • Thrombocytopenia (low platelets)

Immune System Disorders

  • Very rare:
    • Anaphylaxis (severe allergic reaction)
    • Skin rashes, angioedema (swelling)
    • Serious skin reactions (rare cases)

Metabolism & Nutrition Disorders

  • Not known:
    • High anion gap metabolic acidosis (HAGMA), especially in:
      • Sepsis
      • Renal impairment
      • Malnutrition
      • Chronic alcoholism
      • Glutathione deficiency

Respiratory Disorders

  • Very rare:
    • Bronchospasm (more likely in asthmatics sensitive to aspirin/NSAIDs)

Hepatobiliary Disorders

  • Very rare:
    • Hepatic dysfunction (liver damage)

Selected Adverse Reactions Explained

Pyroglutamic Acidosis (HAGMA)

  • May occur due to low glutathione levels
  • Linked to prolonged use or combination with flucloxacillin
  • Recommendation: Discontinue Acetaminophen and monitor closely if suspected

Bronchospasm

  • Rare but possible
  • Higher risk in patients with aspirin-sensitive asthma

Storage instruction of Acetaminophen 500 mg Tablet

Store in a cool, dry place at a temperature below 30°C and away from light.

Keep out of reach of children.

Packing details of Acetaminophen 500 mg Tablet

3×10 Alu/PVC Blister

Acetaminophen 500 mg Tablets is available in an Alu/PVC blister of 10 tablets. Such 03 blisters in a unit carton with a package insert.

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What is 7+4?

Frequently Asked Questions

Questions are useful tools, they open lines of communication; give us information; improve interactions, facilitate analysis, and many more.

A pharma CMO is a special kind of an organization, offering contract manufacturing services to pharmaceutical companies for various kinds of drug formulations.

Reduce overall costs and time to market :
Contract manufacturers already have the needed infrastructure and technical staff, so working with a CMO or CDMO can decrease the cost of manufacturing your pharmaceutical products.

Scalability and flexible production capacity :
You can produce what you need when you need it without worrying about excess capacity. Additionally, CMOs understand the importance of quality and compliance, so you don't have to sacrifice safety for scalability.

Save on upgrading and maintaining equipment :
If you have your manufacturing facility, you’ll have to pay to upgrade your equipment as technology advances—which can get expensive. A CMO/CDMO’s only function is to make and distribute products, so part of their core business responsibility is to update their equipment whenever needed and perform maintenance.

Ease supply chain issues :
During the pandemic, there were several instances of supply chain issues, including medicine shortages. CMOs are generally better equipped than startups to handle a supply chain crisis.

Bandwidth to focus on core competencies
When your company resources aren’t directly allocated to manufacturing and distribution, you have more time to focus on other tasks, like marketing your new drug, researching, or working on drug discovery.

We have 7+ manufacturing sites with a minimum of WHO GMP certification and other country-specific approvals like NAFDAC approved, PPK Kenya Approved, TFDA Tanzania Approved, EU-GMP Approved.

We have below manufacturing capacity:
For Tablet, Capsule, and soft gel: up to 1 million units per shift
For Syrup: up to 0.05 Million per shift
For Ampoule and Vial: up to 0.1 million units per shift
For Ointment and Cream: up to 0.1 million units per shift
For Suppository: 0.1 Million units per shift

What is 7+4?