WISPIRIN- aspirin tablet

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin 81 mg (NSAID)*

PURPOSE

Pain reliever / fever reducer

WARNINGS

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives

facial swelling

asthma (wheezing)

shock

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.
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if the 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

you have asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

anticoagulation (thinning of the blood)

gout

diabetes

arthritis

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away.
Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

pain gets worse or lasts more than 10 days

redness or swelling is present

new symptoms occur

ringing in the ears or loss of hearing occurs

You may report side effects to FDA at 1-800-FDA-1088.
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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

DOSAGE & ADMINISTRATION

drink a full glass of water with each dose

before use, disperse the tablet in water immediately and take the suspension promptly, or swallow the tablet whole with water

do not chew, crush, or split

adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist; do not exceed 48 tablets in 24 hours unless directed by a doctor

children under 12 years of age: ask a doctor

STORAGE AND HANDLING

store at 20-25°C (68-77°F)

protect from moisture

do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT

Hypromellose, Talc, Hypromellose acetate succinate, Hypromellose phthalate, Triethyl citrate, Microcrystalline cellulose, Povidone K30, Crospovidone, Stearic acid, Aspartame, Anhydrous citric acid, Copovidone，Polysorbate 80，Methacrylic acid - ethyl acrylate copolymer，Glyceryl monostearate.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

temporrily relieves minor aches and pains
reduces fever
for adults who have had a heart attack orstroke:helpspreventanother heart attack or stroke (under a doctor's supervision)
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. Ask your doctor about other uses for this product.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WISPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87580-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg  in 265.45 mg

Inactive Ingredients
Ingredient Name	Strength
COPOVIDONE K25-31 (UNII: D9C330MD8B)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)
ASPARTAME (UNII: Z0H242BBR1)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)
HYPROMELLOSES (UNII: 3NXW29V3WO)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87580-001-01	15927 mg in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/15/2026

Labeler - Wisdrug AG (481044776)

Registrant - Wisdrug AG (481044776)

Establishment
Name	Address	ID/FEI	Business Operations
Wisdrug AG		481044776	manufacture(87580-001)