ACETAMINOPHEN- acetaminophen tablet 
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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Major Pharmaceuticals Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

•
temporarily relieves minor aches and pains due to:
•
the common cold
•
headache
•
backache
•
minor pain of arthritis
•
toothache
•
muscular aches
•
premenstrual and menstrual cramps
•
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

•
more than 4,000 mg of acetaminophen in 24 hours
•
with other drugs containing acetaminophen
•
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

•
skin reddening
•
blisters
•
rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

•
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

•
pain gets worse or lasts more than 10 days
•
fever gets worse or lasts more than 3 days
•
new symptoms occur
•
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

•
do not take more than directed (see overdose warning)

adults and children 12 years and over

•
take 2 caplets every 6 hours while symptoms last
•
do not take more than 6 caplets in 24 hours, unless directed by a doctor
•
do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

•
store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-800-616-2471

HOW SUPPLIED

NDC: 71335-9644-1: 20 Tablets in a BOTTLE

NDC: 71335-9644-2: 15 Tablets in a BOTTLE

NDC: 71335-9644-3: 40 Tablets in a BOTTLE

NDC: 71335-9644-4: 100 Tablets in a BOTTLE

NDC: 71335-9644-5: 30 Tablets in a BOTTLE

NDC: 71335-9644-6: 45 Tablets in a BOTTLE

NDC: 71335-9644-7: 50 Tablets in a BOTTLE

NDC: 71335-9644-8: 60 Tablets in a BOTTLE

NDC: 71335-9644-9: 90 Tablets in a BOTTLE

NDC: 71335-9644-0: 250 Tablets in a BOTTLE

Acetaminophen 500mg Tablet

Label
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-9644(NDC:0904-6720)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-9644-120 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
2NDC:71335-9644-215 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
3NDC:71335-9644-340 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
4NDC:71335-9644-4100 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
5NDC:71335-9644-530 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
6NDC:71335-9644-645 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
7NDC:71335-9644-750 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
8NDC:71335-9644-860 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
9NDC:71335-9644-990 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
10NDC:71335-9644-0250 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/26/2018
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-9644) , RELABEL(71335-9644)

Revised: 6/2023
Document Id: 086316dc-3a79-4875-8714-003b96c85dc9
Set id: 4c6e250e-1eef-4b55-ab27-c14a4c26f42c
Version: 101
Effective Time: 20230619
 
Bryant Ranch Prepack