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 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 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:
AUROHEALTH LLC.
279 Princeton- Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

NDC: 58602-776-88Primary Health

Compare to the active ingredient in
Tylenol ® Extra strength Caplets * 

See New Warnings Information & Directions
EXTRA STRENGTH
For Adults
Pain Relief
Acetaminophen Caplets 500 mg
Pain reliever/Fever reducer
N 79

750 CAPLETS
500 mg each

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-776
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: 58602-776-88	750 in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	09/02/2022

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	analysis(58602-776) , manufacture(58602-776)