Indications and uses
for the temporary relief of occasional headaches and minor aches and pains along with accompanying sleeplessness
Extra Strength PM Pain Medicine
- Manufacturer
- Amerisource Bergen | Geri-Care Pharmaceutical Corp
- Effective date
- 2024-10-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:23:27
Label at a glance#
ProductExtra Strength PM Pain Medicine
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 of age Do not use
Storage and handling
• store at controlled room temperature 20-25 °C (68-77° F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Acetaminophen 500 mg
Diphenhydramine HCI 25 mg
Purposes
Pain Reliever
Nighttime sleep aid
Uses
for the temporary relief of occasional headaches and minor aches and pains along 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 • glaucoma • difficulty urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin
• sedatives or tranquilizers
When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks
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 for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition.
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 | Take 2 caplets at bedtime.
Do not take more than 2 caplets of this product in 24 hours. |
| Children under 12 years of age | Do not use |
Other information
• store at controlled room temperature 20-25 °C (68-77° F)
Inactive ingredients
croscarmellose sodium, FD&C blue #1 lake, hypromellose, microcrystalline cellulose, PEG, povidone, silica, starch, stearic acid, titanium dioxide
Questions or comments?
1-800-540-3765
package Label
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 |
|---|---|---|---|---|---|---|
| 46122-799-69 | Extra Strength PM Pain Medicine | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 46122-799-69 | Extra Strength PM Pain Medicine | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 46122-799-70 | Extra Strength PM Pain Medicine | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-799-69 | EA - Each | 46122-799 | 24348568-780f-4ef8-8933-de741e8c2a8c | 1 | 2025-03-04 |
| 46122-799-70 | EA - Each | 46122-799 | 1462bd27-a90c-4aad-a971-9824024a1ac8 | 1 | 2025-03-04 |
Products#
Every source-derived product name is available through these pages.
- Extra Strength PM Pain Medicine
- Acetaminophen, Diphenhydramine HCl
- STARCH, CORN
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- POVIDONE
- FD&C BLUE NO. 1
- CROSCARMELLOSE SODIUM
- HYPROMELLOSES
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STEARIC ACID
- TITANIUM DIOXIDE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 46122-799 | 46122-799-70, 46122-799-69 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 |
|---|---|---|---|---|---|---|
| Extra Strength PM Pain Medicine | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Amerisource Bergen | 23fbda2b-885b-ce00-e063-6294a90a586e | 2024-10-01 | Warnings | 46122-799-70 46122-799-69 46122-799 46122079970 46122079969 23fbc0e1-3e01-acb4-e063-6394a90ac9db 23fbda2b-885b-ce00-e063-6294a90a586e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.