ADULTS LOW STRENGTH ASPIRIN- aspirin tablet

Adults Low Strength Aspirin by

Drug Labeling and Warnings

Adults Low Strength Aspirin by is a Otc medication manufactured, distributed, or labeled by Genvion Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains
• Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief

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
• 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

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 are taking a diuretic
• you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• gout
• diabetes
• arthritis

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 lasts for more than 10 days
• pain persists or gets worse
• new symptoms occur
• redness or swelling is present
• ringing in the ear or loss of hearing occurs. These could be signs 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 right away

Directions

• do not exceed recommended dosage
• drink a full glass of water with each dose
• adults and children 12 years of age and older: take 4 to 8 tablets every 4 hours not to exceed 49 tablets in 24 hours, or as directed by a doctor
• children under 12 years of age: consult a doctor

Other information

Store at controlled room temperature 15º - 30ºC (59º - 86ºF)

Inactive ingredients

hydrophilic pyrogenic silica, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, sodium starch glycolate, pregelatinized starch (Starch 1500), talc, titanium dioxide, triacetin, triethyl citrate

Questions?

For questions regarding this product, please contact 1-204-663-2866

Package Labeling

INGREDIENTS AND APPEARANCE

ADULTS LOW STRENGTH ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62049-001
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	blue (blue)	Score	no score
Shape	ROUND (round)	Size	8mm
Flavor		Imprint Code	C;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62049-001-00	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/01/2015

Labeler - Genvion Corporation (245221226)

Establishment
Name	Address	ID/FEI	Business Operations
Genvion Corporation		245221226	manufacture(62049-001)