OTC Medication Information: Acetaminophen

ACETAMINOPHEN — acetaminophen tablet, extended release
Aurohealth LLC

Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 tablets in 24 hours, which is the maximum daily amount
• 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 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor.
children under 12 years	do not use

Other information

• store at 20^o to 25^o C (68^o to 77^o F). Avoid excessive heat 40^o C (104^o F).
• do not use if carton is opened or foil inner seal is broken
• Meets USP dissolution test 3

Inactive ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

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/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 650 mg (250 Tablet Bottle)

AUROHEALTH
TO OPEN: 1. PUSH DOWN NDC 58602-873-36
2. TURN CAP
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
8 HOUR MUSCLE ACHES & PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For up to 8 Hours Relief of
Minor Muscle Aches & Pain
250 Extended-release tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 650 mg (250 Tablets Container Carton)

AUROHEALTH
NDC 58602-873-36

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

8 HOUR MUSCLE ACHES & PAIN

Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For Up to 8 Hours Relief of
Minor Muscle Aches & Pain
250 Extended-release tablets

ACETAMINOPHEN acetaminophen tablet, extended release

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-873 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE B POTATO TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color WHITE (White to Off-White) Score no score Shape CAPSULE (Caplet) Size 19mm Flavor Imprint Code I;06 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58602-873-36 1 BOTTLE in 1 CARTON contains a BOTTLE 1 250 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (58602-873-36) 2 NDC:58602-873-07 1 BOTTLE in 1 CARTON contains a BOTTLE 2 24 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (58602-873-07) 3 NDC:58602-873-14 1 BOTTLE in 1 CARTON contains a BOTTLE 3 50 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (58602-873-14) 4 NDC:58602-873-21 1 BOTTLE in 1 CARTON contains a BOTTLE 4 100 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (58602-873-21) 5 NDC:58602-873-29 1 BOTTLE in 1 CARTON contains a BOTTLE 5 150 TABLET, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (58602-873-29) 6 NDC:58602-873-34 200 TABLET, EXTENDED RELEASE in 1 BOTTLE None 7 NDC:58602-873-35 225 TABLET, EXTENDED RELEASE in 1 BOTTLE None 8 NDC:58602-873-67 290 TABLET, EXTENDED RELEASE in 1 BOTTLE None 9 NDC:58602-873-76 325 TABLET, EXTENDED RELEASE in 1 BOTTLE None 10 NDC:58602-873-40 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 11 NDC:58602-873-41 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None 12 NDC:58602-873-94 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None 13 NDC:58602-873-44 400 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207229 12/27/2021

Labeler — Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		650381903	ANALYSIS (58602-873), MANUFACTURE (58602-873)

Revised: 06/2023 Aurohealth LLC