Aspirin by Richmond Pharmaceuticals, Inc. / Advance Pharmaceutical Inc. ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Richmond Pharmaceuticals, Inc., Advance Pharmaceutical Inc.. 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

• temporarily relieves minor aches and pains
• for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

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

  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
• takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
• takes more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product.

  Do not use

• if you have ever had an allergic reaction to any other pain reliever / fever reducer

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

  Stop use and ask a doctor if

• you experiences 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
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
• ringing in the ears or a loss of hearing occurs

  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 right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

• adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
• Children under 12 years: ask a doctor

Other Information

• store at 15-30 °C (59-86 °F)

Inactive Ingredients

croscarmellose sodium, D&C Yellow #10 (Al-Lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Safer for your stomach than pain or Buffered Aspirin

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 54738-559-12– 120 Tablets

NDC: 54738-559-25 - 240 Tablets

NDC: 54738-559-03 - 1000 Tablets

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54738-559
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHACRYLIC ACID (UNII: 1CS02G8656)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AP;121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54738-559-12	120 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015
2	NDC: 54738-559-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015
3	NDC: 54738-559-03	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	04/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(54738-559)