Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years do not use
• store at room temperature between 20º-25ºC (68º-77ºF) • protect from light, heat and moisture
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain reliever
Nighttime sleep aid
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• 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
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland • glaucoma
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives and tranquilizers
When using this product
• drowsiness will occur • avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
• pain gets worse or lasts more than 10 days
• fever gets worse or lats more than 3 days.
• redness or swelling is present • new symptoms occur. 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 (1-800-222-1222) right away.
do not take more than directed (see overdose warning)
| adults and children 12 years and over | • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours |
| children under 12 years | do not use |
• store at room temperature between 20º-25ºC (68º-77ºF)
• protect from light, heat and moisture
FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone K30, pregelatinized starch, stearic acid powder, titanium dioxide
Call 1-800-632-6900
Kroger® health
COMPARE TO THE ACTIVE INGREDIENTS OF TYLENOL® PM EXTRA STRENGTH*
NON-HABIT FORMING
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
*Tylenol® is a registered trademark of Kenvue Inc.
PROUDLY DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
PRODUCT OF INDIA
#OUR PHARMACIST RECOMMENDED
Our Brands. Our Guarantee. Love It or Your Money Back.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59450-174-01 | Kroger EXTRA STRENGTH Acetaminophen PM Caplet | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 59450-174-01 | Kroger EXTRA STRENGTH Acetaminophen PM Caplet | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 59450-174-05 | Kroger EXTRA STRENGTH Acetaminophen PM Caplet | 50 in 1 BOTTLE | TABLET | 50 | 2 | |
| 59450-174-05 | Kroger EXTRA STRENGTH Acetaminophen PM Caplet | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 59450-174-20 | Kroger EXTRA STRENGTH Acetaminophen PM Caplet | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 59450-174-20 | Kroger EXTRA STRENGTH Acetaminophen PM Caplet | 2 in 1 CARTON | TABLET | 2 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59450-174 | 59450-174-05, 59450-174-01, 59450-174-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| Kroger EXTRA STRENGTH Acetaminophen PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | 24a75ffa-c2a7-71a9-e063-6394a90a0e25 | 2024-12-17 | Warnings | 59450-174-01 59450-174-20 59450-174-05 59450-174 59450017401 59450017405 59450017420 bef8542c-67a4-4d65-8c1b-b3db699efffe 24a75ffa-c2a7-71a9-e063-6394a90a0e25 |
Adverse event summaries are temporarily unavailable. Other product information remains available.