Unishield Cramp

Manufacturer
Unishield | Unifirst First Aid Corporation
Effective date
2022-03-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:46

Label at a glance#

ProductUnishield Cramp
Active ingredientACETAMINOPHEN, PAMABROM
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 325 mg

Pamabrom 25 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Diuretic

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves headache, bloating, cramps, backache, water-weight gain, muscular aches and pains associated with the menstrual period.

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, which is the maximum daily amount

■ 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.

■ for more than 10 days for pain unless directed by a doctor

■ for more than 3 days for fever unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if

■ you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose.

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ symptoms do not improve

■ new symptoms occur

■ pain or fever persists or gets worse

■ redness or swelling is present

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 overdose, get medical help or contact a Poison Control Center 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

■ drink 6 to 8 glasses of water each day while you are taking the tablets

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed.
Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ avoid excessive heat and humidity

■ tamper-evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, microcrystalline cellulose,

povidone, starch, stearic acid, sucrose

OTC - QUESTIONS SECTION

Questions or comments? 800-480-5856

Unishield Cramp Tabs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unishield

Cramp Tabs

Menstrual Relief

100 Tablets/ 1 Tablet Per Packet

Acetaminophen 325 mg

Pamabrom 25 mg

Pull To Open

This Package is for Households without Young Children.

• Reduces water-weight gain

• Relieves headaches, backaches and muscular aches & pains

Relieves Cramps and Bloating

Tamper Evident Unit Dose Packets

810810

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313784acetaminophen 325 MG / pamabrom 25 MG Oral TabletPSN3
313784acetaminophen 325 MG / pamabrom 25 MG Oral TabletSCD3
313784APAP 325 MG / pamabrom 25 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49314-8103-32023-07-28C16284748780-10191ceaa-62d7-198a-e063-dbdaa90aec3eUnishield Cramp Tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49314-8103-3Unishield Cramp2 in 1 PACKETTABLET, FILM COATED23
49314-8103-3Unishield Cramp50 in 1 BOXTABLET, FILM COATED503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49314-8103UNISHIELD CRAMP (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNISHIELD]3Legacy NDC, 2 package rows20220317_b9d37cad-9b0c-1ab9-e053-2a95a90a5f1d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49314-810349314-8103-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
da5a27d2-b0ac-68ba-e053-2995a90afa63b9d37cad-9b0c-1ab9-e053-2a95a90a5f1d2022-03-16WarningsExact identifier
spl id: da5a27d2-b0ac-68ba-e053-2995a90afa63
spl set id: b9d37cad-9b0c-1ab9-e053-2a95a90a5f1d

Reported adverse events (FAERS/openFDA)#

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