Indications and 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
Acetaminophen Extra Strength
- Manufacturer
- KROGER COMPANY | Aurohealth LLC | APL HEALTHCARE LIMITED
- Effective date
- 2024-10-21
- Label type
- Human OTC Drug Label
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:28:38
Label at a glance#
ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure16 sections
Dosage and administration
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
Storage and handling
store between 20° to 25°C (68° to 77°F) do not use is carton is open or printed foil seal under cap is torn or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each caplet)
Acetaminophen USP 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 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
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
- store between 20° to 25°C (68° to 77°F)
- do not use is carton is open or printed foil seal under cap is torn or missing.
Inactive ingredients
povidone, pregelatinized starch (maize), stearic acid.
Questions or comments?
1-800-632-6900
DISTRIBUTED BY HE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA
Code: TS/DRUGS/16/2014
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Caplets Bottle)
NDC 30142-033-07
Kroger®
health
FOR ADULTS
EXTRA STRENGTH
Acetaminophen
500 mg
PAIN RELIEVER/ 24 CAPLETS
FEVER REDUCER 500 mg EACH
SEE NEW WARNINGS INFORMATION & DIRECTIONS
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Caplets Bottle Carton)
NDC 30142-033-07
Kroger®
health
COMPARE TO THE ACTIVE INGREDIENT
IN TYLENOL® EXTRA STRENGTH CAPLETS*
SEE NEW WARNINGS INFORMATION & DIRECTIONS
EXTRA STRENGTH FOR ADULTS
Acetaminophen 500 mg
PAIN RELIEVER/ 24 CAPLETS
FEVER REDUCER 500 mg EACH
DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN
ACTUAL SIZE
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 30142-033-07 | Acetaminophen Extra Strength | 24 in 1 BOTTLE | TABLET | 24 | 5 | |
| 30142-033-07 | Acetaminophen Extra Strength | 1 in 1 CARTON | TABLET | 1 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Extra Strength
- Acetaminophen
- POVIDONE K30
- STARCH, CORN
- PALMITOSTEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 30142-033 | 30142-033-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| PALMITOSTEARIC ACID | Q8Y7S3B85M | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen Extra Strength | ACETAMINOPHEN | KROGER COMPANY | cf63c372-acdd-6e6e-e053-2995a90a1662 | 2024-10-21 | Warnings | 30142-033-07 30142-033 30142003307 abae08b0-d2ce-4263-9a67-5065a8a3059d cf63c372-acdd-6e6e-e053-2995a90a1662 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.