ACETAMINOPHEN EXTRA STRENGTH - acetaminophen tablet 
KROGER COMPANY

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Drug Facts

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

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

Do not use

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

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
  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions or comments?

1-800-632-6900

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by: THE KROGER CO.
CINCINNATI, OHIO 45202
Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)

NDC 30142-068-07
Kroger® For Adults
Extra Strength
Acetaminophen
500 mg
Pain Reliever,
Fever Reducer
24
RAPID
RELEASE
GELCAPS
500 mg each



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton)

COMPARE TO the active ingredient in EXTRA STRENGTH
TYLENOL® RAPID RELEASE GELS *See top panel
NDC 30142-068-07

Kroger® For Adults
Extra Strength
Acetaminophen
500 mg
Pain Reliever, Fever Reducer
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
actual
size
24
RAPID
RELEASE GELCAPS
500 mg each



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton)
ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-068
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (and Blue with Grey Band) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code J;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-068-071 in 1 CARTON02/04/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:30142-068-351 in 1 CARTON04/26/2021
2225 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:30142-068-241 in 1 CARTON04/22/2024
3100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM01302/04/2021
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(30142-068) , MANUFACTURE(30142-068)

Revised: 4/2024
Document Id: 6f52dbfd-579a-4d0d-97e2-bb354f6848dd
Set id: b96a2280-ec4f-7c61-e053-2995a90a18bb
Version: 5
Effective Time: 20240418
 
KROGER COMPANY