ASPIRIN LOW DOSE- aspirin tablet, coated 
Bryant Ranch Prepack

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each tablet)

Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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 if your are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

These can 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

Other information

Inactive ingredients

cellulose,D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, PEG, polydextrose, silica, simethicone, sodium
bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Questions or comments?

1-800-540-3765

HOW SUPPLIED

NDC: 71335-0622-8: 15 Tablets in a BOTTLE

NDC: 71335-0622-1: 120 Tablets in a BOTTLE

NDC: 71335-0622-2: 30 Tablets in a BOTTLE

NDC: 71335-0622-3: 100 Tablets in a BOTTLE

NDC: 71335-0622-4: 20 Tablets in a BOTTLE

NDC: 71335-0622-5: 90 Tablets in a BOTTLE

NDC: 71335-0622-6: 60 Tablets in a BOTTLE

NDC: 71335-0622-7: 36 Tablets in a BOTTLE

NDC: 71335-0622-9: 10 Tablets in a BOTTLE

Aspirin 81 mg EC Tablet

Label
ASPIRIN  LOW DOSE
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0622(NDC:57896-981)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0622-815 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
2NDC:71335-0622-1120 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2018
3NDC:71335-0622-230 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2018
4NDC:71335-0622-3100 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2018
5NDC:71335-0622-420 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
6NDC:71335-0622-590 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2018
7NDC:71335-0622-660 in 1 BOTTLE; Type 0: Not a Combination Product08/22/2018
8NDC:71335-0622-736 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2018
9NDC:71335-0622-910 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/01/2000
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0622) , RELABEL(71335-0622)

Revised: 3/2023
Document Id: 32a85ae5-2546-483f-a183-168ead487af2
Set id: 61ecf3c9-42fa-4ae4-bd3b-694090477b9a
Version: 3
Effective Time: 20230329
 
Bryant Ranch Prepack