FDA.reportPublic FDA data

Extra Strength Night Time Pain Medicine

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2024-05-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:15:17

Label at a glance#

ProductExtra Strength Night Time Pain Medicine
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

• 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

• store at controlled room temperature 20-25 °C (68-77° F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever

Sleep aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin

• sedatives or tranquilizers

When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks

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 for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition.

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: 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

• do not take more than directed (see overdose warning)

Adults and Children 12 years and overTake 2 caplets at bedtime.
Do not take more than 2 caplets of this product in 24 hours.
Children under 12 yearsDo not use.

Other information

STORAGE AND HANDLING SECTION

• store at controlled room temperature 20-25 °C (68-77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue #1 lake, hypromellose, microcrystalline cellulose, PEG, povidone, silica, starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD5
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY5

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
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
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-224-012022-11-17C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224
57896-224-052022-11-17C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224
57896-224-012022-01-28C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224
57896-224-052022-01-28C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224
57896-224-012020-12-14C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224
57896-224-052020-12-14C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224
57896-224-012020-01-31C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224
57896-224-052020-01-31C16284748780-19d75b9d0-74fb-f424-e053-dadaa90a57ceGC 224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-224-01Extra Strength Night Time Pain Medicine100 in 1 BOTTLETABLET1005
57896-224-05Extra Strength Night Time Pain Medicine50 in 1 BOTTLETABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-224EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20240716_2b8f83ed-1ca9-49ac-9b2a-2609b68200f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-224-01EA - Each57896-224beee89e1-ed91-4409-87f7-7d65ffba370712015-09-10
57896-224-05EA - Each57896-22405606da6-56f3-4981-87e2-19714b19069012018-10-11

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
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-22457896-224-01, 57896-224-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
POVIDONEFZ989GH94EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Night Time Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp2b8f83ed-1ca9-49ac-9b2a-2609b68200f92024-05-21WarningsExact identifier
ndc (package): 57896-224-01
ndc (package): 57896-224-05
ndc (product): 57896-224
ndc11 (package): 57896022405
ndc11 (package): 57896022401
spl id: 18fc1ad1-3502-bb79-e063-6394a90abac9
spl set id: 2b8f83ed-1ca9-49ac-9b2a-2609b68200f9

Reported adverse events (FAERS/openFDA)#

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