Indications and uses
Uses temporary relief of minor aches and pains, such as leg cramp pain, joint pain, lower backache, and sore feet, with accompanying sleeplessness.
Legatrin PM
- Manufacturer
- Church & Dwight Co., Inc. | ULTRAtab
- Effective date
- 2019-10-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:08:45
Label at a glance#
ProductLegatrin PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections
Dosage and administration
Directions Do not exceed recommended dosage. Adults and children 12 years of age and older 1 caplet at bedtime as needed, or as directed by a doctor Children under 12 years consult a doctor
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCI 50 mg
Purposes
Purposes
Acetaminophen - Pain Reliever
Diphenhydramine HCI - Sleep Aid
Uses
Uses
temporary relief of minor aches and pains, such as leg cramp pain, joint pain, lower backache, and sore feet, with accompanying sleeplessness.
Warnings
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
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a docotr or pharmacist.
- with any other product containing dephenhydramine, even one used on skin
- in children under 12 years of age
Ask Doctor
Ask a doctor before use if you have
- liver disease
- glaucoma
- breathing problem such as asthma, emphysema, chronic bronchitis or pulmonary disease
- trouble urinating due to an enlarged prostate gland
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Ask a doctor or pharmacist before use if you are
- taking tranquilizers or sedatives
- taking the blood thinning drug warfarin
When using this product
When using this product
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
- avoid alcoholic drinks
Stop Use
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 for more than 10 days
- fever gets worse or lasts for more than 3 days
- symptoms do not improve within 7 days or are accompanied by a fever
- new symptoms occur
- redness or swelling is present
- nervousness, dizziness or sleeplessness occur
If pregnany or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions
- Do not exceed recommended dosage.
Adults and children 12 years of age and older | 1 caplet at bedtime as needed, or as directed by a doctor |
| Children under 12 years | consult a doctor |
Other Information
Other information
- store at controlled room temperature 20° to 25° C (68° to 77° F)
- avoid excessive heat and humidity
- tamper evident. Do not use if carton is opened or neck wrap or foil inner seal is broken.
- see end panel for lot number and expiration date.
Inactive Ingredients
Inactive ingredients
colloidal silicon dioxide, corn starch, FD&C blue #1, hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid
Package Label. Principal Display Panel LegatrinPM
Just 1 caplet
helps you sleep!
SAFE, NON-HABIT FORMING
Contains Acetaminophen,
Diphenhydramine HCI
LegatrinPM
Pain Reliever/Sleep Aid
Relieves lower
body pain
Leg Cramp Pain
Joint Pain
Lower Backache
Sore Feet
50 Caplets
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10237-907-50 | 2024-06-08 | C162847 | 48780-1 | f386c64a-4599-0266-e053-dadaa90a7c1a | Legatrin PM Pain Reliever/Sleep Aid |
| 10237-907-50 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4599-0266-e053-dadaa90a7c1a | Legatrin PM Pain Reliever/Sleep Aid |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Products#
Every source-derived product name is available through these pages.
- Legatrin PM
- Acetaminophen, Diphenhydramine HCI
- POLYETHYLENE GLYCOL 400
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- SILICON DIOXIDE
- STARCH, CORN
- FD&C BLUE NO. 1
- HYPROMELLOSES
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE
- STEARIC ACID
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-907 | 10237-907-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EXTENDED RELEASE / ORAL | 3239 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | FILM, SOLUBLE / ORAL | 19 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EFFERVESCENT / ORAL | 14404 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | INSERT / VAGINAL | 54.21 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg |
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 |
|---|---|---|---|---|---|---|
| e552806e-b94e-4a74-8519-fed9096f96d8 | 058be7e6-01cb-5cd6-e054-00144ff88e88 | 2024-06-06 | Warnings | 058be7e6-01cb-5cd6-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.