PAIN RELIEVER- acetaminophen tablet, film coated

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by HHH PHARMA USA LLC, Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses:

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3000 mg) in 24 hours. Severe liver damage may occur if you take

• more than 4000 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: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 of age and over:
• take 2 caplets every 6 hours while symptoms last
• do not take mote than 6 caplets in 24 hours
• do not use for more than 10 days unless directed by a doctor
• children under 12 years of age: do not use

Other information

• store at 15° to 30°C (59° to 86°F)
• read all product information before using

Inactive ingredients

Pregelatinized Starch, Povidone, Stearic Acid powder, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose 5 & 15, Polyethylene Glycol, Titanium Dioxide, Talc

Questions or comments?

Call +1 848-235-5293 Mon - Fri 9 AM - 5 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVER 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83586-107
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
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	S500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83586-107-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/12/2025

Labeler - HHH PHARMA USA LLC (062788820)

Registrant - HHH PHARMA USA LLC (062788820)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		863182240	manufacture(83586-107)

Establishment
Name	Address	ID/FEI	Business Operations
HHH PHARMA USA LLC		062788820	pack(83586-107)