EXTRA STRENGTH ASPIRIN- aspirin tablet, film coated

Extra Strength Aspirin by

Drug Labeling and Warnings

Extra Strength Aspirin 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 tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

temporary relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

• hives
• shock
• facial swelling
• asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

• if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

• you have asthma
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor's care for any serious condition
• taking any other drug

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
• an allergic reaction occurs. Seek medical help right away.
• ringing in the ears or a loss of hearing occurs
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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

• drink a full glass of water with each dose
• adults and children 12 years and over:
  take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
• children under 12 years:ask a doctor

Other information

• store at room temperature 15-30ºC (59-86ºF)
• read all product information before using

Inactive ingredients

Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Talc, Titanium Dioxide

Questions or comments?

Call +1-848-235-5293

Monday through Friday 9AM – 4PM EST

Principal Display Panel

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83586-115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASP325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83586-115-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/28/2025

Labeler - HHH PHARMA USA LLC (062788820)

Registrant - HHH PHARMA USA LLC (062788820)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		863182240	manufacture(83586-115)

Establishment
Name	Address	ID/FEI	Business Operations
HHH PHARMA USA LLC		062788820	pack(83586-115)