Unishield PMS Relief

Manufacturer
Unishield | Unifirst First Aid Corporation
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:32

Label at a glance#

ProductUnishield PMS Relief
Active ingredientPAMABROM, PYRILAMINE MALEATE, ACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

Diuretic

Antihistamine

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of these symptoms associated with menstrual periods:

■ headache

■ bloating

■ cramps

■ backache

■ muscular aches

■ irritability

■ water-weight gain

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

If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

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.

■ if you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

■ liver disease

■ glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets with water every 6 hours as needed

■ do not exceed 6 caplets in a 24 hour period or as directed by a doctor

Children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at 77°F (25°C); excursions permitted between 59°-86°F (15°-30°C)

■ tamper-evident sealed packets

■ do not use any opened or torn packets

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

OTC - QUESTIONS SECTION

Questions or comments? 800-480-5855

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unishield

PMS Relief

Menstrual Relief

80 caplets / 2 Caplets Per Packet

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine Maleate 15 mg

Pain Reliever, Diuretic, Antihistamine

Pull To Open

This Package is for Households Without Young Children.

• Reduces water-weight gain

• Relieves headaches, backaches and muscular aches and pains

Relieves Cramps and Bloating

Tamper Evident Unit Dose Packets

Unishield 823Unishield 823

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49314-8238-0Unishield PMS Relief40 in 1 BOXTABLET, FILM COATED402
49314-8238-0Unishield PMS Relief2 in 1 PACKETTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49314-8238UNISHIELD PMS RELIEF (ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE) TABLET, FILM COATED [UNISHIELD]2Legacy NDC, 2 package rows20240118_e7116d33-86be-35a7-e053-2a95a90a8532.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
49314-823849314-8238-0

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
0f2883d8-a7bd-f0d1-e063-6294a90a35fee7116d33-86be-35a7-e053-2a95a90a85322024-01-17WarningsExact identifier
spl id: 0f2883d8-a7bd-f0d1-e063-6294a90a35fe
spl set id: e7116d33-86be-35a7-e053-2a95a90a8532

Reported adverse events (FAERS/openFDA)#

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