SPL v3
SPL
SPL Set ID cf649478-57d2-cc88-e053-2a95a90ad1ba
Route
ORAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Povidone K30 Starch, Corn Palmitostearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: N74 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-02
Description

Active ingredient (in each tablet) Acetaminophen USP 325 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each tablet) Acetaminophen USP 325 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • temporarily reduces fever
Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 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 tablet)



Acetaminophen USP 325 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?

1-800-632-6900

 

Distributed by: THE KROGER CO.

CINCINNATI, OHIO 45202



MADE IN INDIA



Code: TS/DRUGS/16/2014



Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 Before Use If the User Has

liver disease

Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin

Package Label Principal Display Panel 325 Mg (100 Tablets Bottle)

NDC 30142-052-21



Kroger ®



Regular Strength

Acetaminophen Tablets

325 mg

Pain Reliever/

Fever Reducer



100

TABLETS

325 mg EACH







Package Label Principal Display Panel 325 Mg (100 Tablets Bottle Carton)

COMPARE TO the active ingredient of                                                        NDC 30142-052-21

REGULAR STRENGTH TYLENOL ®TABLETS *See top panel

Kroger ®



Regular Strength

Acetaminophen Tablets

325 mg

Pain Reliever/Fever Reducer

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN



actual

size



100TABLETS

325 mg EACH







Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 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 tablet)



Acetaminophen USP 325 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?)

1-800-632-6900

 

Distributed by: THE KROGER CO.

CINCINNATI, OHIO 45202



MADE IN INDIA



Code: TS/DRUGS/16/2014



Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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.

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

ask a health professional before use.

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 Before Use If the User Has (Ask a doctor before use if the user has)

liver disease

Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)

taking the blood thinning drug warfarin

Package Label Principal Display Panel 325 Mg (100 Tablets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle))

NDC 30142-052-21



Kroger ®



Regular Strength

Acetaminophen Tablets

325 mg

Pain Reliever/

Fever Reducer



100

TABLETS

325 mg EACH







Package Label Principal Display Panel 325 Mg (100 Tablets Bottle Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle Carton))

COMPARE TO the active ingredient of                                                        NDC 30142-052-21

REGULAR STRENGTH TYLENOL ®TABLETS *See top panel

Kroger ®



Regular Strength

Acetaminophen Tablets

325 mg

Pain Reliever/Fever Reducer

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN



actual

size



100TABLETS

325 mg EACH







Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.779671 · Updated: 2026-03-14T23:02:00.533418