Acetaminophen Extra Strength Tablet
FDA Label NDC 30142-033

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Acetaminophen Extra Strength (NDC 30142-033). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

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

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.

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

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

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.

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.

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

Other Information

  • store between 20° to 25°C (68° to 77°F)
  • do not use is carton is open or 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 HE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

Code: TS/DRUGS/16/2014

Package Label-Principal Display Panel 500 Mg (24 Caplets Bottle)

NDC 30142-033-07
Kroger®
for adults
Extra Strength
Acetaminophen
Caplets 500 mg
Pain Reliever/
Fever Reducer
SEE NEW WARNINGS
INFORMATION &
DIRECTIONS

24
CAPLETS
500 mg EACH



Package Label-principal Display Panel 500 mg ( 100 Caplets Bottle) (Acetaminophen Fig1)

Package Label-principal Display Panel 500 mg ( 100 Caplets Bottle) (Acetaminophen Fig1)

Package Label-Principal Display Panel 500 Mg (24 Caplets Bottle Carton)

COMPARE TO the active ingredient of                                        NDC 30142-033-07
EXTRA STRENGTH TYLENOL® CAPLETS *See top panel
Kroger®
for adults
SEE NEW WARNINGS
INFORMATION  & DIRECTIONS

Extra Strength
Acetaminophen Caplets
500 mg
Pain Reliever/Fever Reducer
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

actual
size

24 CAPLLETS
500 mg EACH



Acetaminophen-fig2.jpg (Acetaminophen Fig2)

Acetaminophen-fig2.jpg (Acetaminophen Fig2)


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