ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet 
Aurohealth LLC

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Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP 325 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

Allergy alert:acetaminophen may cause severe skin reactions.
Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Ask a doctor before use if the user has

liver disease

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

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

 

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 years
ask a doctor

Other information

Inactive ingredients

povidone, pregelatinized starch (maize), stearic acid.

Questions or comments?

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 325 mg (100 Tablets Bottle)

AUROHEALTH
NDC 58602-775-21

REGULAR STRENGTH
Pain Relief
Acetaminophen
Tablets 325 mg

Pain Reliever/
Fever Reducer

100
Tablets
325 mg each



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle Carton)

AUROHEALTH
NDC 58602-775-21
Compare to the active ingredient in
Tylenol ®Regular Strength tablets *

RREGULAR STRENGTH
Acetaminophen
Tablets 325 mg

Pain Reliever/Fever Reducer

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Actual size

100
Tablets
325 mg each



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle Carton)

ACETAMINOPHEN REGULAR STRENGTH 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-775
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
Product Characteristics
Colorwhite (White to off White) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code N74
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-775-211 in 1 CARTON02/02/2022
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/02/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777analysis(58602-775) , manufacture(58602-775)

Revised: 11/2023
Document Id: 0b4563cf-6c4a-fcd5-e063-6294a90ae597
Set id: cc0ab7a1-e535-4dc8-962f-c58949fc1737
Version: 2
Effective Time: 20231129
 
Aurohealth LLC