ENTERIC COATED ASPIRIN REGULAR STRENGTH- aspirin tablet, delayed release 
Bryant Ranch Prepack

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331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets

DRUG FACTS

Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

Uses
temporarily relieves minor aches and pains due to:

or as recommended by a doctor

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments? call 1-877-290-4008

HOW SUPPLIED

NDC: 71335-0157-1: 30 Tablets in a BOTTLE

NDC: 71335-0157-2: 60 Tablets in a BOTTLE

NDC: 71335-0157-3: 100 Tablets in a BOTTLE

NDC: 71335-0157-4: 90 Tablets in a BOTTLE

NDC: 71335-0157-5: 20 Tablets in a BOTTLE

NDC: 71335-0157-6: 45 Tablets in a BOTTLE

NDC: 71335-0157-7: 120 Tablets in a BOTTLE

NDC: 71335-0157-8: 7 Tablets in a BOTTLE

Aspirin E.C 325mg Tablet

Label
ENTERIC COATED ASPIRIN  REGULAR STRENGTH
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0157(NDC:49483-331)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0157-130 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
2NDC:71335-0157-260 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
3NDC:71335-0157-3100 in 1 BOTTLE; Type 0: Not a Combination Product04/19/2018
4NDC:71335-0157-490 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
5NDC:71335-0157-520 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
6NDC:71335-0157-645 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
7NDC:71335-0157-7120 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
8NDC:71335-0157-87 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/04/2011
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0157) , RELABEL(71335-0157)

Revised: 1/2024
Document Id: dbc8764f-05fc-4f24-a235-0522ce30ea35
Set id: e05140fa-9766-4f97-bffc-e36a01b9d38f
Version: 6
Effective Time: 20240124
 
Bryant Ranch Prepack