EXTRA STRENGTH MINI SOFTGELS PAIN RELIEVER- acetaminophen capsule, liquid filled

Extra Strength Mini Softgels Pain Reliever by

Drug Labeling and Warnings

Extra Strength Mini Softgels Pain Reliever by is a Otc medication manufactured, distributed, or labeled by THE KROGER CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredient

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

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 youhave liver disease

Ask a doctor or pharmacist before use if you aretaking 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)

Inactive ingredients

FD & C Red # 40, gelatin, glycerin, polyethylene glycol 40, polyethylene glycol 400, povidone, purified water, sorbitan solution, titanium dioxide

Questions or comments?

1-800-632-6900

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient
in Tylenol® Extra Strength

Extra Strength Mini Softgels Pain Reliever

Acetaminophen 500 mg

Label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH MINI SOFTGELS PAIN RELIEVER 
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-101
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEG-40 (UNII: HAF0412YIT)
POVIDONE (UNII: FZ989GH94E)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	SD31
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-101-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/27/2026

Labeler - THE KROGER CO (006999528)