BJs Acetaminophen 500 mg and Diphenhydramine HCl 25 mg Tablets
- Manufacturer
- BJWC (Berkley & Jensen / BJ's) | TIME CAP LABORATORIES INC | TIME CAP LABORATORIES INC.
- Effective date
- 2025-09-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:12:18
Label at a glance#
ProductExtra Strength Acetaminophen PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever
Nighttime sleep aid
INDICATIONS & USAGE SECTION
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
OTC - STOP USE SECTION
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
Do not take more than directed. See overdose warning.
adults and children 12 years and over |
|
children under 12 years | do not use |
OTHER SAFETY INFORMATION
Other information
- store between 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue#1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide
**may contain this ingredient
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68391-430-50 | Extra Strength Acetaminophen PM | 500 in 1 BOTTLE | TABLET | 500 | 2 |
Products#
Every source-derived product name is available through these pages.
- Extra Strength Acetaminophen PM
- Acetaminophen, Diphenhydramine
- MICROCRYSTALLINE CELLULOSE
- TALC
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STARCH, CORN
- SILICON DIOXIDE
- CARNAUBA WAX
- STEARIC ACID
- TITANIUM DIOXIDE
- FD&C BLUE NO. 1 ALUMINUM LAKE
- POLYVINYL ALCOHOL, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68391-430 | 68391-430-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Extra Strength Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE | BJWC (Berkley & Jensen / BJ's) | 2f473f1f-7cf3-2af5-e063-6394a90aaa17 | 2025-09-01 | Warnings | 68391-430-50 68391-430 68391043050 3becb4c1-6d93-4349-e063-6294a90a0a52 2f473f1f-7cf3-2af5-e063-6394a90aaa17 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.