Aspirin by Bryant Ranch Prepack ASPIRIN tablet, coated

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

EACH TABLET CONTAINS; ASPIRIN 81 MG (nsaid)* NON STEROIDAL ANTI-INFLAMMATORY DRUG

Inactive Ingredients

anhydrous lactose, carnauba wax, collodidal silicon dioxide, croscarmellose sodium, d&c yellow #10 aluminumlake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, tatanim dioxide, triethyl citrate

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, consul a doctor

INDICATIONS & USAGE

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 becausse serious side effects may occur.

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-lie 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 allergic reaction, which may include, hives, facial swelling, shock, 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.

PURPOSE

Pain Reliever

KEEP OUT OF REACH OF CHILDREN

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

HOW SUPPLIED

Product: 71335-0195

NDC: 71335-0195-6 60 TABLET, COATED in a BOTTLE

NDC: 71335-0195-7 36 TABLET, COATED in a BOTTLE

NDC: 71335-0195-1 120 TABLET, COATED in a BOTTLE

NDC: 71335-0195-4 20 TABLET, COATED in a BOTTLE

NDC: 71335-0195-5 90 TABLET, COATED in a BOTTLE

NDC: 71335-0195-2 30 TABLET, COATED in a BOTTLE

NDC: 71335-0195-3 100 TABLET, COATED in a BOTTLE

Aspirin 81 mg EC Tablet

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0195(NDC: 0536-1004)
Route of Administration	ORAL	DEA Schedule	CIV

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-0195-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
2	NDC: 71335-0195-7	36 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
3	NDC: 71335-0195-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
4	NDC: 71335-0195-4	20 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
5	NDC: 71335-0195-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
6	NDC: 71335-0195-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
7	NDC: 71335-0195-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/14/2014

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0195) , RELABEL(71335-0195)