ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH- acetaminophen tablet 
Aurex Laboratories Limited Liability Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Adwe Feverx Acetaminophen Caplets, 500 mg

Active Ingredient: Acetaminophen 500 mg

Uses:

Minor aches and pains, fever.

Warnings

Liver warninig: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets in 24 hours. Severe liver damage may occur if you take:

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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

These could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If pregnant or breast-feeding, ask a health professional before use.

Directions:

Other information

Inactive ingredients:

microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.

* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.

Distributed By:

Adwe Laboratories

1274 49 St. Brooklyn, NY 11219

This product contains no animal, soybean, or grain derivatives.

This product does not contain any Chometx or Krtnius.

REV 0221

Label
ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71009-109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code A;A2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71009-109-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/09/2021
Labeler - Aurex Laboratories Limited Liability Company (067585317)
Registrant - Adwe Products & Imports Inc. (080081765)
Establishment
NameAddressID/FEIBusiness Operations
Aurex Laboratories Limited Liability Company067585317MANUFACTURE(71009-109)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceuticals, Corp038883275REPACK(71009-109)

Revised: 3/2021
Document Id: 58ea72c2-7049-45ce-ac0c-4b6df46819b6
Set id: 948c5826-6f35-484d-bb3f-cecf6a4b5c13
Version: 4
Effective Time: 20210308
 
Aurex Laboratories Limited Liability Company