Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Pain Relief PM
- Manufacturer
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Effective date
- 2024-06-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:13:37
Label at a glance#
ProductPain Relief PM Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
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
Storage and handling
store between 20-25°C (68-77°F) in a dry place retain carton for complete product information
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients
(in each caplet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep aid |
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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.
- 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 or 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 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.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
PRINCIPAL DISPLAY PANEL
QUALITY CHOICE®
NDC 83324-085-01
†Compare to Active Ingredients in TYLENOL® PM Extra Strength Caplets
For Adults
Extra Strength
Pain Relief PM
Acetaminophen, Diphenhydramine HCl
Pain Reliever, Nighttime Sleep Aid
Actual Size
100 CAPLETS
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 |
|---|---|---|---|---|---|---|
| 83324-085-01 | Pain Relief PMExtra Strength | 1 in 1 CARTON | TABLET, COATED | 1 | 2 | |
| 83324-085-01 | Pain Relief PMExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 2 | |
| 83324-085-50 | Pain Relief PMExtra Strength | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 2 | |
| 83324-085-50 | Pain Relief PMExtra Strength | 1 in 1 CARTON | TABLET, COATED | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83324-085 | PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] | 2 | Current NDC, 4 package rows | 20240615_3ce5bbf2-d449-464e-abeb-5c26866d1ab5.zip |
Products#
Every source-derived product name is available through these pages.
- Pain Relief PM Extra Strength
- Acetaminophen and Diphenhydramine Hydrochloride
- SILICON DIOXIDE
- COPOVIDONE K25-31
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 1
- HYPROMELLOSES
- LACTOSE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- STARCH, PREGELATINIZED CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83324-085 | 83324-085-50, 83324-085-01 |
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 |
|---|---|---|---|---|---|---|
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3ce5bbf2-d449-464e-abeb-5c26866d1ab5 | 2024-06-13 | Warnings | 83324-085-01 83324-085-50 83324-085 83324008550 83324008501 1ac8a196-00fa-a986-e063-6294a90a948f 3ce5bbf2-d449-464e-abeb-5c26866d1ab5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.