ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated 
United Natural Foods, Inc. dba UNFI

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.

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1004-ELN-2022-0915

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

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

Inactive ingredients

hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-855-423-2630

PRINCIPAL DISPLAY PANEL

Equaline®

NDC 41163-500-01

compare to Extra Strength Tylenol® Caplets active ingredient*

extra strength

acetaminophen caplets

pain reliever/fever reducer

for adults

24 caplets - 500 mg each

actual size

image description

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code M2A4;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-500-011 in 1 CARTON11/01/2013
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:41163-500-021 in 1 CARTON11/01/201305/31/2020
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:41163-500-041 in 1 CARTON11/01/2013
3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:41163-500-051 in 1 CARTON11/01/201312/01/2019
4250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:41163-500-061 in 1 CARTON11/01/2013
5500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:41163-500-171 in 1 CARTON11/01/201303/31/2018
6150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2013
Labeler - United Natural Foods, Inc. dba UNFI (943556183)

Revised: 5/2023
Document Id: fbe56804-3ecd-af55-e053-6394a90a3fbc
Set id: f3db8598-fe0e-4c53-a023-5f5f8f002cc6
Version: 6
Effective Time: 20230517
 
United Natural Foods, Inc. dba UNFI