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← See all Acetaminophen Extra Strength brands

Acetaminophen Extra Strength by Supervalu Inc.

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Supervalu Inc.
NDC Code: 41163-500

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.

ELN - 1004 - 2015-0326

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

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

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 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
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

Equaline

NDC 41163-500-02

compare to Extra Strength Tylenol® Caplets active ingredient*

extra strength

acetaminophen caplets

500mg

pain reliever/fever reducer

aspirin free

50 caplets

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint CodeM2A4;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-500-011 BOTTLE, PLASTIC in 1 CARTON
124 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:41163-500-021 BOTTLE, PLASTIC in 1 CARTON
250 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:41163-500-041 BOTTLE, PLASTIC in 1 CARTON
3100 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:41163-500-051 BOTTLE, PLASTIC in 1 CARTON
4250 TABLET, COATED in 1 BOTTLE, PLASTIC
5NDC:41163-500-061 BOTTLE, PLASTIC in 1 CARTON
5500 TABLET, COATED in 1 BOTTLE, PLASTIC
6NDC:41163-500-171 BOTTLE, PLASTIC in 1 CARTON
6150 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2013
Labeler - Supervalu Inc. (006961411)

 
Supervalu Inc.

← See all Acetaminophen Extra Strength brands

Medically reviewed on Apr 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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