FDA Label for Acetaminophen Extra Strength

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

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. 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 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps 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 at 20° to 25°C (68° to 77°F). Avoid high humidity
• do not use if carton is open. Do not use if printed foil seal under cap is torn or missing

Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments?

1-800-632-6900

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by: THE KROGER CO.
CINCINNATI, OHIO 45202
Made in India

Code: TS/DRUGS/16/2014

Package Label-Principal Display Panel 500 Mg (24 Gelcaps Container Label)

NDC 30142-068-07
Kroger_® For Adults
Extra Strength
Acetaminophen
500 mg
Pain Reliever,
Fever Reducer
24
RAPID
RELEASE
GELCAPS
500 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label) - acetaminophen fig1

Package Label-Principal Display Panel 500 Mg (24 Gelcaps Container Carton)

COMPARE TO the active ingredient in EXTRA STRENGTH
TYLENOL^® RAPID RELEASE GELS ^*See top panel
NDC 30142-068-07

Kroger_® For Adults
Extra Strength
Acetaminophen
500 mg
Pain Reliever, Fever Reducer
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
actual
size
24 RAPID
RELEASE GELCAPS
500 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton) - acetaminophen fig2