PM Get Relief

Manufacturer
Eagle Distributors,Inc.
Effective date
2012-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:24

Label at a glance#

ProductPM Get Relief
Active ingredientAcetaminophen, Diphenhydramine Hydrochloride
Label structure10 sections

Indications and uses

temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

Adults and children 12 years of age and over Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. Children under 12 years of age Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems

Storage and handling

store between20-25 C (68-77 F) do not use if pouch is torn or open

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purposes
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking 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

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. 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

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and overTake 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
Children under 12 years of ageDo not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems

Other information

STORAGE AND HANDLING SECTION

  • store between20-25 C (68-77 F)
  • do not use if pouch is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-570-8650 (M-F 9am to 5pm PST)

SPL UNCLASSIFIED SECTION

Product manufactured for:
Eagle Distributors,Inc.
Los Angeles, CA 90011

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions
Compare to the Active Ingredients in
Tylenol PM ®*

Extra Strength
PM
Get Relief

Pain Reliever
Nighttime Sleep Air

Acetaminophen, Diphenhydramine HCI

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton
PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD1
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68737-224-082019-11-13C16284748780-197449f38-d1db-f6ea-e053-dbdaa90aa703PM Get Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68737-224-08PM Get Relief50 in 1 BOXTABLET501
68737-224-08PM Get Relief2 in 1 POUCHTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68737-224PM GET RELIEF (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [EAGLE DISTRIBUTORS,INC.]1Legacy NDC, 2 package rows20120630_05703022-d12c-4c1b-b995-b772ffa3e861.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD401
AcetaminophenACTIVE MOIETY362O9ITL9D1
DiphenhydramineACTIVE MOIETY8GTS82S83M1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH481
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBD1
hypromellosesINACTIVE INGREDIENT3NXW29V3WO1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A1
polyvinyl alcoholINACTIVE INGREDIENT532B59J9901
povidoneINACTIVE INGREDIENTFZ989GH94E1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
talcINACTIVE INGREDIENT7SEV7J4R1U1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68737-22468737-224-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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 6 · 311 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
talcTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii candidate
30 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
27 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
27 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii candidate
30 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET / SUBLINGUAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE / ORAL72 mgExact identifier — unii candidate
22 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii candidate
27 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48POWDER, FOR SUSPENSION / ORAL11.25 mgExact identifier — unii candidate
22 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE PELLETS / ORAL127 mgExact identifier — unii candidate
22 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
talcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48GRANULE / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii candidate
17 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, EXTENDED RELEASE / ORAL392 mgExact identifier — unii candidate
22 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48INJECTION / INTRAMUSCULAR1 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FOR SUSPENSION / ORAL1875 mgExact identifier — unii candidate
22 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii candidate
22 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii candidate
27 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOSYSTEM / TOPICAL54 mgExact identifier — unii candidate
27 equally ranked IID candidates
povidonePOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii candidate
27 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8bf7e7ac-aa38-4ba5-8c4f-55d15e27f7b005703022-d12c-4c1b-b995-b772ffa3e8612012-06-11WarningsExact identifier
spl id: 8bf7e7ac-aa38-4ba5-8c4f-55d15e27f7b0
spl set id: 05703022-d12c-4c1b-b995-b772ffa3e861

Reported adverse events (FAERS/openFDA)#

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