Indications and uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
leader headache pm formula
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2018-02-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:03:19
Label at a glance#
Productleader headache pm formula
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: leader headache pm formula
GENERIC: Acetaminophen, Diphenhydramine HCl
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-0824-0
COLOR: blue
SHAPE: ROUND
SCORE: No score
SIZE: 11 mm
IMPRINT: L355;PM
PACKAGING: 50 in 1 BOTTLE
ACTIVE INGREDIENT(S):
- ACETAMINOPHEN 500mg in 1
- DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1
INACTIVE INGREDIENT(S):
- CARNAUBA WAX
- POLYSORBATE 80
- POLYETHYLENE GLYCOLS
- POVIDONE
- STEARIC ACID
- CELLULOSE, MICROCRYSTALLINE
- CROSPOVIDONE
- HYPROMELLOSES
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-0824-0 | 2020-05-13 | C162847 | 48780-1 | 9d75b9cf-e4c8-f424-e053-dadaa90a57ce | Cardinal Health Headache PM Formula Drug Facts |
| 70518-0824-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e4c8-f424-e053-dadaa90a57ce | Cardinal Health Headache PM Formula Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37205-677-71 | EA - Each | 37205-677 | 41f73291-6851-4112-ba6b-6a53728f266b | 1 | 2014-07-02 |
Products#
Every source-derived product name is available through these pages.
- leader headache pm formula
- Acetaminophen, Diphenhydramine HCl
- CARNAUBA WAX
- CROSPOVIDONE
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOLS
- POLYSORBATE 80
- POVIDONE
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-0824 | 70518-0824-0 |
| 37205-677 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CROSPOVIDONE | 68401960MK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| a4fdb7d5-82b9-44b1-e053-2995a90a3b3e | 92790a4e-7d75-459f-af6f-32bd7da82f25 | 2020-05-06 | Warnings | 92790a4e-7d75-459f-af6f-32bd7da82f25 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.