ACETAMINOPHEN- acetaminophen tablet, coated 
Kroger Company

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Kroger Extra Strength Acetaminophen Rapid Release Tablets

Drug Facts

Acetaminophen 500 mg

Acetaminophen 500 mg

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

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 are allergic to acetaminophen or any of the inactive ingredients in this product

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

adults and children 12 years and over

children under 12 years

OTHER INFORMATION

Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, mica based pearlescent pigment, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch

Questions or comments? Call 1-800-632-6900

apap-rr-225s-labelapap-rr-100s-labelapap-rr-100s-ifcacetaminophen 500 mg-24ct-carton

acetaminophen 500 mg-24ct-Bottle label

ACETAMINOPHEN 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-697
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICA (UNII: V8A1AW0880)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULE (biconvex tablets) Size17mm
FlavorImprint Code TCL;A71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-697-421 in 1 CARTON04/10/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41226-697-34225 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
3NDC:41226-697-011 in 1 CARTON04/15/2024
3100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/10/2021
Labeler - Kroger Company (006999528)
Registrant - Time Cap Laboratories, Inc. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-697)

Revised: 4/2024
Document Id: 15f7c6af-1e4d-c8ee-e063-6394a90a9e58
Set id: bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e
Version: 3
Effective Time: 20240413
 
Kroger Company