Extra Strength Pain Reliever

Extra Strength Pain Reliever by

Drug Labeling and Warnings

Extra Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc., Auro Packaging, LLC, APL Health Care Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRA STRENGTH PAIN RELIEVER- acetaminophen caplet, 500 mg tablet, film coated 
Lil' Drug Store Products, Inc.

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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Extra Strength Pain Reliever

Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP 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

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

  • 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° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, pregelatinized starch
(maize), propylene glycol, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Compare to the Active
Ingredient in Tylenol®
Extra Strength Caplets**

[caduceus]

Extra Strength

Pain Reliever

Acetaminophen 500 mg
Pain Reliever/Fever Reducer

[caplets image]

ACTUAL SIZE

24
Caplets [Lil' Drug Store logo]

PDP

Compare to the Active
Ingredient in Tylenol®
Extra Strength Caplets**

[caduceus]

Extra Strength

Pain Reliever

Acetaminophen 500 mg
Pain Reliever/Fever Reducer

[caplets image]

ACTUAL SIZE

24
Caplets [Lil' Drug Store logo]

PDP

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen caplet, 500 mg tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66715-6967
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Coloryellow (White to off-white) Scoreno score
ShapeOVAL (capsule-shaped biconvex) Size18mm
FlavorImprint Code N79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66715-6967-41 in 1 CARTON09/07/202103/31/2025
124 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 finalpart34309/07/202103/31/2025
EXTRA STRENGTH PAIN RELIEVER 
acetaminophen caplets, 500 mg tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66715-6971
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorwhite (White to off-white) Scoreno score
ShapeOVAL (capsule-shaped biconvex) Size18mm
FlavorImprint Code N79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66715-6971-41 in 1 CARTON09/20/202103/31/2025
150 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 finalpart34309/20/202103/31/2025
Labeler - Lil' Drug Store Products, Inc. (093103646)
Establishment
NameAddressID/FEIBusiness Operations
Auro Packaging, LLC080970298pack(66715-6967, 66715-6971) , label(66715-6967, 66715-6971)
Establishment
NameAddressID/FEIBusiness Operations
APL Health Care Limited650844777manufacture(66715-6967, 66715-6971) , analysis(66715-6967, 66715-6971)

Revised: 11/2022
Document Id: ed243841-0307-24fd-e053-2a95a90a7bdf
Set id: d07442a5-7d42-cc25-e053-2a95a90aecb5
Version: 2
Effective Time: 20221110