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Pain Relief Extra Strength by International Laboratories, LLC

Medically reviewed on April 6, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: International Laboratories, LLC
NDC Code: 54458-861

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.

International Laboratories, Inc. Pain Relief 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
• muscular aches
• toothache
• premenstrual and menstrual cramps

  • temporarily reduces fever

Warnings

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.

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 of pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

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
• new symptoms occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
These could be signs of a serious condition.

Do not

 give to children under 3 years of age.

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 at 20-25ºC (68-77ºF)

Inactive ingredients

 carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinzed starch, sodium starch glycolate*, stearic acid
*may contain one or more of these ingredients

Questions or comments?

 1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

Extra Strength Pain Relief Drug Facts

 

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Extra Strength Tylenol®

See New Warnings

EXTRA STRENGTH

Pain Relief

ACETAMINOPHEN 500 mg

Pain reliever; Fever reducer

For adults

14 CAPLETS

Actual Size

LIFT HERE TO OPEN

 

Extra Strength Pain Relief Display Panel

PAIN RELIEF EXTRA STRENGTH 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-861(NDC:59779-484)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size16mm
FlavorImprint CodeL484
Contains    
Packaging
#Item CodePackage Description
1NDC:54458-861-1414 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/27/2016
Labeler - International Laboratories, LLC (023569924)
Establishment
NameAddressID/FEIOperations
International Laboratories, LLC023569924RELABEL(54458-861), REPACK(54458-861)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company078716293MANUFACTURE(54458-861), RELABEL(54458-861), REPACK(54458-861)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company006013346MANUFACTURE(54458-861), RELABEL(54458-861), REPACK(54458-861)

 
International Laboratories, LLC

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Further information

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

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