SPL v5
SPL
SPL Set ID 5c42dd28-820c-4cc5-9016-11ad5e580616
Route
ORAL
Published
Effective Date 2014-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC24 Shape: capsule Color: red Size: 24 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-06
Description

Drug Facts

Purpose

Pain reliever/ fever reducer

Medication Information

Purpose

Pain reliever/ fever reducer

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if the user hasliver disease.

Section 53414-9

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

Warnings

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 6 softgels (3,000 mg) in 24 hours. 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
Directions
  • Do not take more than directed (see Overdose warning)

Adults and children 12 years of age and over
  • take 2 softgels every 4 to 6 hours while symptoms last
  • do not take more than 6 softgels in 24 hours unless directed by a doctor
  • do not take more than 10 days unless diredted by doctor

Children 12 years of age

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 have ever had an allergic reaction to this product or any of its ingredients
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.

Other Information
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

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.

Active Ingredient (in Each Capsule)

Acetaminophen 500 mg

Principal Display Panel Shipping Label

ACETAMINOPHEN CAPSULES, 500 mg

Quantity : 3000 Capsules

NDC. No : 53345-019-01

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if the user hasliver disease.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/ fever reducer

Warnings

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 6 softgels (3,000 mg) in 24 hours. 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
Directions
  • Do not take more than directed (see Overdose warning)

Adults and children 12 years of age and over
  • take 2 softgels every 4 to 6 hours while symptoms last
  • do not take more than 6 softgels in 24 hours unless directed by a doctor
  • do not take more than 10 days unless diredted by doctor

Children 12 years of age

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 have ever had an allergic reaction to this product or any of its ingredients
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.

Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Acetaminophen 500 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

ACETAMINOPHEN CAPSULES, 500 mg

Quantity : 3000 Capsules

NDC. No : 53345-019-01

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:32.388114 · Updated: 2026-03-14T23:05:21.514130