Indications and uses
• for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Leader Headache Relief PM
- Manufacturer
- Cardinal Health
- Effective date
- 2019-01-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:35:03
Label at a glance#
ProductLeader Headache Relief PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
• do not use more than directed (see overdose warning) • adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor • do not take more than 2 tablets of this product in 24 hours • children under 12 years of age: do not use
Storage and handling
• store at 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each tablet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
(equiv. to Diphenhydramine citrate 38 mg)
Purposes
Pain reliever
Nighttime sleep-aid
Uses
- for the 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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
- drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for 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 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 use more than directed (see overdose warning)
- adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor
- do not take more than 2 tablets of this product in 24 hours
- children under 12 years of age: do not use
Other information
- store at 20-25°C (68-77°F)
Inactive ingredients
carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
1-800-719-9260
Principal Display Panel
Headache Relief PM
Acetaminophen, 500 mg
Diphenhydramine HCl, 25 mg
Pain Reliever | Nighttime Sleep-Aid
COMPARE TO EXCEDRIN® PM active ingredients
For Adults
Aspirin Free
Non-Habit Forming
50 COATED TABLETS
100% Money Back Guarantee
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0303-1 | EA - Each | 70000-0303 | 4ef3d09d-3920-41c7-a00b-a5dcb793929b | 1 | 2018-07-03 |
Products#
Every source-derived product name is available through these pages.
- Leader Headache Relief PM
- Acetaminophen, Diphenhydramine HCl
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CARNAUBA WAX
- CROSPOVIDONE (15 MPA.S AT 5%)
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL
- POLYSORBATE 80
- POVIDONE
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0303 | 70000-0303-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CROSPOVIDONE (15 MPA.S AT 5%) | 68401960MK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| 61a15841-fe48-40b9-b67a-33e1da0342cc | a51524fd-5229-4529-955e-a762fb6cc4a7 | 2020-12-03 | Warnings | a51524fd-5229-4529-955e-a762fb6cc4a7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.