Extra Strength Aspirin by Health Pharma USA LLC Extra Strength Aspirin

Extra Strength Aspirin by

Drug Labeling and Warnings

Extra Strength Aspirin by is a Otc medication manufactured, distributed, or labeled by Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRA STRENGTH ASPIRIN- extra strength aspirin tablet 
Health Pharma USA LLC

----------

Extra Strength Aspirin

Drug facts

Purpose

Pain reliever/ Fever reducer

Active ingredient (in each tablet)

Aspirin 325mg

Uses

Temporarily 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 behaviour 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 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
  • taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if:

  1. 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

2. an allergic reaction occurs.

  • seek medical help right away.

3. ringing in the ears or loss of hearing occurs

4. pain gets worse or lasts for more than 3 days

5. redness or swelling present

6. new symptoms occur

These could be sign of a serious condition.

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

  • Do not take more than directed
  • Drink a full glass of water with each dose
  • Adults and children 12 years of age and over:
  1. take 1 to 2 tablets every 4 hours while symptoms last
  2. do not take more than 12 tablets in 24 hours unless directed by a doctor
  3. do not use for more than 10 days unless directed by a doctor
  • Children under 12 years: do not use unless directed by a doctor

Other Information

  • Store at controlled room temperature 25°C (77°F) excursions permitted between 15-30°C (59-86°F)

Inactive ingredients

  • Corn starch
  • Carnauba Wax
  • Hypromellose
  • Polyethylene Glycol
  • Povidone
  • Talc
  • Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST www.healthpharma.us

Extra Strength Aspirin

Aspirin 325 mg

Compare to Bayer® EXTRA STRENGTH active ingredients

325

EXTRA STRENGTH ASPIRIN 
extra strength aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71679-050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POVIDONE (UNII: FZ989GH94E)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71679-050-001 in 1 CARTON08/01/202003/31/2025
149605 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/01/202003/31/2025
Labeler - Health Pharma USA LLC (080804485)
Establishment
NameAddressID/FEIBusiness Operations
Health Pharma USA LLC080804485manufacture(71679-050)

Revised: 5/2025
 

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.