Storage and handling
Other information store at room temperature
Extra Strength Acetaminophen PM
- Manufacturer
- Cardinal Health
- Effective date
- 2018-08-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:52:26
Label at a glance#
ProductExtra Strength Acetaminophen PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections
Contacts and useful links#
Websitewww.myleader.com
www.myleader.com
www.myleader.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purposes
Pain Reliever
Nighttime Sleep Aid
INDICATIONS & USAGE SECTION
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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.
in children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
if you have ever had an allergic reaction to this product or any of its ingredients
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
liver disease
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery
OTC - STOP USE SECTION
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 more than 10 days
- fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present
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.
OVERDOSAGE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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: do not use
STORAGE AND HANDLING SECTION
Other information
- store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or Comments?
call ( 800) 795-9775
OTHER SAFETY INFORMATION
Do not use if carton is open, or if imprinted safety seal under cap is broken or missing.
SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70000-0149-1
LEADER™
Extra Strength
Acetaminophen PM
Acetaminophen 500 mg, Diphenhydramine HCl, 25 mg Caplets
Pain Reliever | Sleep Aid
Non-Habit Forming
24 CAPLETS
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0149-1 | EA - Each | 70000-0149 | 85c7539d-46a7-4d25-befa-7eec309f2534 | 1 | 2018-12-13 |
| 70000-0149-2 | EA - Each | 70000-0149 | 3d88b0ed-665d-4262-8c05-3432179926f1 | 1 | 2017-12-14 |
| 70000-0149-3 | EA - Each | 70000-0149 | 6b593738-949f-46f2-b517-1f6a21f5889c | 1 | 2018-12-13 |
Products#
Every source-derived product name is available through these pages.
- Extra Strength Acetaminophen PM
- Acetaminophen and Diphenhydramine HCl
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- STARCH, PREGELATINIZED CORN
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 1
- CELLULOSE, MICROCRYSTALLINE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- POVIDONES
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CROSPOVIDONE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0149 | 70000-0149-1, 70000-0149-3, 70000-0149-2 |
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 |
|---|---|---|---|---|---|---|
| 7483340b-6090-4fc4-e053-2991aa0a7503 | 41eac1e2-dfa8-2b99-e054-00144ff8d46c | 2018-08-28 | Warnings | 7483340b-6090-4fc4-e053-2991aa0a7503 41eac1e2-dfa8-2b99-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.