EXTRA STRENGTH PAIN RELIEVER- acetaminophen caplet, 500 mg tablet, film coated EXTRA STRENGTH PAIN RELIEVER- acetaminophen caplets, 500 mg tablet, film coated

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]

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)

PRINCIPAL DISPLAY PANEL

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]

PRINCIPAL DISPLAY PANEL

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]

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen caplet, 500 mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6967
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (White to off-white)	Score	no score
Shape	OVAL (capsule-shaped biconvex)	Size	18mm
Flavor		Imprint Code	N79
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6967-4	1 in 1 CARTON	09/07/2021	03/31/2025
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/07/2021	03/31/2025

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen caplets, 500 mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6971
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (White to off-white)	Score	no score
Shape	OVAL (capsule-shaped biconvex)	Size	18mm
Flavor		Imprint Code	N79
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6971-4	1 in 1 CARTON	09/20/2021	03/31/2025
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/20/2021	03/31/2025

Labeler - Lil' Drug Store Products, Inc. (093103646)

Establishment
Name	Address	ID/FEI	Business Operations
Auro Packaging, LLC		080970298	pack(66715-6967, 66715-6971) , label(66715-6967, 66715-6971)

Establishment
Name	Address	ID/FEI	Business Operations
APL Health Care Limited		650844777	manufacture(66715-6967, 66715-6971) , analysis(66715-6967, 66715-6971)