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 20o to 25o C (68o to 77o F). Avoid excessive heat 40o C (104o 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 Tablet Bottle)
(click image for full-size original)

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 650 mg (250 Tablets Container Carton)
(click image for full-size original)

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: 01/2024 Aurohealth LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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