Extra Strength Night Time Pain Medicine

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2024-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:48:30

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 ache 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 ache 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 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, FD&C blue #1 lake,
FD&C blue #2 lake, hypromellose, magnesium
stearate, PEG, polyvinyl alcohol, povidone,
purified water, silicon dioxide, sodium starch
glycolate, starch, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-324EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]3Legacy NDC20241130_e5450e02-b2f2-aaf9-e053-2995a90a4c30.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-324-01EA - Each57896-324efe3c6ab-219f-40ba-8d8d-6b1f05c3628312023-08-08
57896-324-05EA - Each57896-3240fed182d-e884-47e9-9aba-8c68a74ea6ca12022-10-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-32457896-324-01, 57896-324-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

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
27fdd9bd-5587-8ced-e063-6394a90a3c63e5450e02-b2f2-aaf9-e053-2995a90a4c302024-11-28WarningsExact identifier
spl id: 27fdd9bd-5587-8ced-e063-6394a90a3c63
spl set id: e5450e02-b2f2-aaf9-e053-2995a90a4c30

Reported adverse events (FAERS/openFDA)#

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