FEM-PRIN

Manufacturer
HART Health
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:40:25

Label at a glance#

ProductFEM-PRIN
Active ingredientPAMABROM, PYRILAMINE MALEATE, ACETAMINOPHEN
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Diuretic

Antihistamine

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches, pain, and water weight gain due to mentrual cycle

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription).

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ liver disease

■ glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if 

■ you do not know if other drugs you are taking contain acetaminophen

■ you are taking sedatives or tranquilizers

■ you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ an allergic reaction occurs, seek medical help right away

■ fever worsens or lasts more than 3 days

■ pain worsens or lasts more than 10 days

■ new symptoms occur

■ redness or swelling is present

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. 

DOSAGE & ADMINISTRATION SECTION

Directions

Do not take more than directed

Adults and children 12 years of age and over

■ take 2 caplets every 6 hours while symptoms persist

■ do not take more than 6 caplets in 24 hours unless directed by a doctor

Children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information:

■ caplets enclosed in a sealed packet

■ do not use if packet is torn, cut or open

■ store at 59° to 86°F (15°-30°C)

■ avoid excessive heat and humidity

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Femprin.jpgFemprin.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052637acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletPSN2
1052637acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletSCD2
1052637APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0145-42026-01-29C16284748780-149896155-c95f-586f-e063-e6dba90add90FEM-PRIN
50332-0145-72026-01-29C16284748780-149896155-c95f-586f-e063-e6dba90add90FEM-PRIN

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0145FEM-PRIN (ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE) TABLET, FILM COATED [HART HEALTH]2Unmatched20241206_d8516e5b-3087-4c29-9290-989cf800d34c.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-014550332-0145-4, 50332-0145-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
76d2433e-c480-42cb-8416-57a71e733967d8516e5b-3087-4c29-9290-989cf800d34c2024-12-04WarningsExact identifier
spl id: 76d2433e-c480-42cb-8416-57a71e733967
spl set id: d8516e5b-3087-4c29-9290-989cf800d34c

Reported adverse events (FAERS/openFDA)#

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