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#
Contacts and useful links#
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
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
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49314-8103-3 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-62d7-198a-e063-dbdaa90aec3e | Unishield Cramp Tabs |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49314-8103-3 | Unishield Cramp | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 3 | |
| 49314-8103-3 | Unishield Cramp | 50 in 1 BOX | TABLET, FILM COATED | 50 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49314-8103 | UNISHIELD CRAMP (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNISHIELD] | 3 | Legacy NDC, 2 package rows | 20220317_b9d37cad-9b0c-1ab9-e053-2a95a90a5f1d.zip |
Products#
Every source-derived product name is available through these pages.
- Unishield Cramp
- Acetaminophen, Pamabrom
- CELLULOSE, MICROCRYSTALLINE
- ACETAMINOPHEN
- PAMABROM
- BROMOTHEOPHYLLINE
- D&C YELLOW NO. 10
- SUCROSE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- STARCH, CORN
- POVIDONE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49314-8103 | 49314-8103-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PAMABROM | UA8U0KJM72 | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| SUCROSE | C151H8M554 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| da5a27d2-b0ac-68ba-e053-2995a90afa63 | b9d37cad-9b0c-1ab9-e053-2a95a90a5f1d | 2022-03-16 | Warnings | da5a27d2-b0ac-68ba-e053-2995a90afa63 b9d37cad-9b0c-1ab9-e053-2a95a90a5f1d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
