ASPIRIN tablet, film coated

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Yichang Humanwell Pharmaceutical Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• for the temporary relief of minor aches and pains or as recommended by your doctor.

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

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

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

ASK DOCTOR

Ask a doctor before use if

• 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 have asthma
• you are taking a diuretic

ASK DOCTOR/PHARMACIST

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

• gout
• diabetes
• arthritis

STOP USE

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• 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
• any new symptoms occur
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs

These could be signs of a serious illness.

PREGNANCY 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

Keep out of reach of children.

OVERDOSAGE

In case of accidental overdose, get medical help or contact a poison control center right away.

Directions

• drink a full glass of water with each dose
• adults and children 12 years and over: take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor

Other information

• store at 15-25ºC (59-77ºF)
• protect from heat, humidity, and light

Inactive ingredients

colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, ferrosoferric oxide, glyceryl monostearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, polyvinyl alcohol, povidone, pregelatinized starch, shellac, sodium bicarbonate, sodium lauryl sulfate, talc, triethyl citrate, and titanium dioxide.

PRINCIPAL DISPLAY PANEL

Quantity: 70,000 Tablets

NDC No.: 62732-8005-1

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62732-8005
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
SHELLAC (UNII: 46N107B71O)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
METHACRYLIC ACID (UNII: 1CS02G8656)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POVIDONE (UNII: FZ989GH94E)
POLYVINYL ALCOHOL (UNII: 532B59J990)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	81E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62732-8005-1	70000 in 1 BAG; Type 0: Not a Combination Product	12/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	12/14/2016

Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)