ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet

Acetaminophen Extra Strength by

Drug Labeling and Warnings

Acetaminophen Extra Strength by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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®
            health

FOR ADULTS
EXTRA STRENGTH

Acetaminophen
500 mg

PAIN RELIEVER/                24 CAPLETS
FEVER REDUCER               500 mg EACH

SEE NEW WARNINGS INFORMATION & DIRECTIONS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Caplets Bottle Carton)

NDC: 30142-033-07

Kroger®
            health

COMPARE TO THE ACTIVE INGREDIENT
IN TYLENOL® EXTRA STRENGTH CAPLETS*

SEE NEW WARNINGS INFORMATION  & DIRECTIONS

EXTRA STRENGTH            FOR ADULTS

Acetaminophen 500 mg

PAIN RELIEVER/                24 CAPLETS
FEVER REDUCER               500 mg EACH

DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-033
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)

Product Characteristics
Color	WHITE (White to off White)	Score	no score
Shape	CAPSULE (Biconvex)	Size	18mm
Flavor		Imprint Code	N79
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-033-07	1 in 1 CARTON	02/02/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/02/2022

Labeler - KROGER COMPANY (006999528)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(30142-033) , MANUFACTURE(30142-033)