FDA.reportPublic FDA data

Excedrin PM Triple Action Caplets

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-14
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:09:51

Label at a glance#

ProductExcedrin PM Triple Action Caplets
Active ingredientACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE
Label structure9 sections

Indications and uses

• for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

• do not use more than directed • do not use in children under 12 years of age • adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water • do not take more than 2 caplets in 24 hours, unless directed by a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain Reliever

Pain Reliever

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • 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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have glaucoma
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking

  • a prescription drug for:
    • diabetes
    • gout
    • arthritis
  • any other drug, or are under a doctor’s care for any serious condition
  • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
  • sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • pain gets worse or last for more than 10 days
  • painful area is red or swollen
  • ringing in the ears or a loss of hearing occurs
  • any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • do not use in children under 12 years of age
  • adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each caplet contains: 75 mg calcium
  • store at 20°-25°C (68°-77°F).
  • close cap tightly after use.
  • read all product information before using. Keep this box for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, calcium carbonate, FD&C blue no. 1 aluminum lake, ferric oxide yellow, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, zinc stearate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-468-7746

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXCEDRIN

PM HEADACHE

Acetaminophen 250 mg, Aspirin 250 mg (NSAID)

and Diphenhydramine Citrate 38 mg

Pain Reliever/Nighttime Sleep-Aid

Caffeine-Free

Non-Habit Forming

ACTUAL SIZE

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: Haleon, Warren, NJ 07059

©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000201994

Excedrin PM Headache 24 ct
Excedrin PM Headache 24 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN9
1593116Excedrin PM Triple Action (250 MG / 250 MG / 38 MG) Oral TabletPSN9
1593116acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action]SBD9
1593110acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral TabletSCD9
1593110APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral TabletSY9
1593116APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [Excedrin PM Triple Action]SY9
1593116Excedrin PM Triple Action (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG) Oral TabletSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2056-24Excedrin PM Triple Action Caplets24 in 1 BOTTLETABLET, COATED249
0067-2056-24Excedrin PM Triple Action Caplets1 in 1 CARTONTABLET, COATED19
0067-2056-91Excedrin PM Triple Action Caplets1 in 1 CARTONTABLET, COATED19
0067-2056-91Excedrin PM Triple Action Caplets100 in 1 BOTTLETABLET, COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2056EXCEDRIN PM TRIPLE ACTION CAPLETS (ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 4 package rows20240316_b3812d27-40af-40d7-864a-dfa4ae34cb9e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2056-24EA - Each0067-20567e87628e-bc22-4b84-9a6e-a4656f14ae2512015-05-05
0067-2056-91EA - Each0067-2056dc2a5514-d77d-410f-9573-d3b77755873912018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S2091
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
ASPIRINACTIVE MOIETYR16CO5Y76E1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K141
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FV1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-20560067-2056-24, 0067-2056-91

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
DIPHENHYDRAMINE CITRATE4OD433S209ACTIB
BENZOIC ACID8SKN0B0MIMIACT
CALCIUM CARBONATEH0G9379FGKIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED2165RE0K14IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ZINC STEARATEH92E6QA4FVIACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 2 · 87 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii+route
21 equally ranked IID candidates
ZINC STEARATEZINC STEARATEH92E6QA4FVTABLET, COATED / ORAL1.82 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET / ORAL480 mgExact identifier — unii+route
12 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route
21 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii+route
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii+route
21 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route
9 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii+route
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
21 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14CAPSULE / ORAL150 mgExact identifier — unii+route
12 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route
21 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii+route
21 equally ranked IID candidates
ZINC STEARATEZINC STEARATEH92E6QA4FVTABLET, COATED / ORAL1.82 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route
9 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
21 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET, FILM COATED / ORAL40 mgExact identifier — unii+route
12 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET, FILM COATED / ORAL40 mgExact identifier — unii+route
12 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route
21 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route
9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET, FILM COATED / ORAL40 mgExact identifier — unii+route
12 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route
9 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii+route
21 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14TABLET, DELAYED RELEASE / ORAL103 mgExact identifier — unii+route
12 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, EXTENDED RELEASE / ORAL22 mgExact identifier — unii+route
9 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14CAPSULE / ORAL150 mgExact identifier — unii+route
12 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii+route
21 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route
9 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii+route
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
21 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE2165RE0K14CAPSULE / ORAL150 mgExact identifier — unii+route
12 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC444fa225-c204-45d1-b3b3-aa5650ee5d072026-02-23WarningsExact identifier
ndc (package): 0067-2056-24
ndc11 (package): 00067205624
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
ndc (package): 0067-2056-24
ndc11 (package): 00067205624
Excedrin PM Triple Action CapletsACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLCb3812d27-40af-40d7-864a-dfa4ae34cb9e2024-03-14WarningsExact identifier
ndc (package): 0067-2056-91
ndc (package): 0067-2056-24
ndc (product): 0067-2056
ndc11 (package): 00067205691
ndc11 (package): 00067205624
spl id: 8304e801-1a21-42b1-ad99-dd8621be478a
spl set id: b3812d27-40af-40d7-864a-dfa4ae34cb9e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.