SPL v2
SPL
SPL Set ID 10ee2f40-858d-bed4-e063-6394a90a86bb
Route
ORAL
Published
Effective Date 2024-05-17
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone K30 Starch, Corn Palmitostearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: N79 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-15
Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

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 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

If pregnant or breast-feeding, ask a

health professional before use.

Warnings

Liver warning: This product contains acetaminophen.

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

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 take 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 6 caplets in 24 hours, unless directed by a doctor
  • do not use for 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
Drug Facts

Active ingredient (in each caplet)



Acetaminophen USP 500 mg

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is open or if printed foil seal under cap is torn or missing.
Inactive Ingredients

povidone, pregelatinized starch (maize), stearic acid.

Questions Or Comments?

call 1-855-274-4122

DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N.

SEATTLE, WA 98109

Made in India

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.

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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Package Label Principal Display Panel 500 Mg (100 Caplets Bottle)

amazon

basic+care

Extra Strength

NDC 72288-692-10

See New Warnings Information

& Directions

Acetaminophen

Caplets 500 mg

Pain Reliever/Fever Reducer

For Adults

Contains No Aspirin

100 CAPLETS

500 mg EACH

Package Label Principal Display Panel 500 Mg (100 Caplets Bottle Carton)

amazon

basic+care

Extra Strength

NDC 72288-692-10

Compare to

Extra Strength

Tylenol® Caplets

active ingredient*

See New Warnings Information & Directions

Acetaminophen

Caplets 500 mg

Pain Reliever/Fever Reducer

For Adults

Contains No Aspirin

100 CAPLETS

500 mg EACH



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 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a

health professional before use.

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen.

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

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 take 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 6 caplets in 24 hours, unless directed by a doctor
  • do not use for 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
Drug Facts

Active ingredient (in each caplet)



Acetaminophen USP 500 mg

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is open or if printed foil seal under cap is torn or missing.
Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized starch (maize), stearic acid.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N.

SEATTLE, WA 98109

Made in India

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.)

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.

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

Package Label Principal Display Panel 500 Mg (100 Caplets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle))

amazon

basic+care

Extra Strength

NDC 72288-692-10

See New Warnings Information

& Directions

Acetaminophen

Caplets 500 mg

Pain Reliever/Fever Reducer

For Adults

Contains No Aspirin

100 CAPLETS

500 mg EACH

Package Label Principal Display Panel 500 Mg (100 Caplets Bottle Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle Carton))

amazon

basic+care

Extra Strength

NDC 72288-692-10

Compare to

Extra Strength

Tylenol® Caplets

active ingredient*

See New Warnings Information & Directions

Acetaminophen

Caplets 500 mg

Pain Reliever/Fever Reducer

For Adults

Contains No Aspirin

100 CAPLETS

500 mg EACH



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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:06.215550 · Updated: 2026-03-14T23:02:58.626725