Dosage and administration
do not take more than directed (see overdose warning0 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
Pain Relief PM
- Manufacturer
- Allegiant Health
- Effective date
- 2021-11-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:57:00
Label at a glance#
ProductPain Relief PM Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient(s)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep aid
Use(s)
temporarily 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 4000 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
- 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.
- You may report side effects to 1-888-952-0050
Pregnancy/Breastfeeding
If pregnant or breastfeeding, 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. 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 warning0
- 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
Other information
- store between 20-25 °C (68-77° F)
- do not use if imprinted safety seal under cap is broken or missing
- retain carton for full product information
Inactive ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene
glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
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 |
|---|---|---|---|---|---|---|
| 69168-003-50 | Pain Relief PMExtra Strength | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 69168-003-50 | Pain Relief PMExtra Strength | 50 in 1 BOTTLE | TABLET | 50 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Pain Relief PM Extra Strength
- Pain Relief PM
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 1 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- SILICON DIOXIDE
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69168-003 | 69168-003-50 |
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 |
|---|---|---|---|---|---|---|
| Pain Relief PM Extra Strength | PAIN RELIEF PM | Allegiant Health | 4c9969be-a01f-4ca4-800a-e404229ce28b | 2021-11-23 | Warnings | 69168-003-50 69168-003 69168000350 d3d02f1a-47df-498e-871d-58e79640fe81 4c9969be-a01f-4ca4-800a-e404229ce28b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.