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Drug Facts
Unishield Cramp
FDA Label NDC 49314-8103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield Cramp (NDC 49314-8103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 325 mg
Pamabrom 25 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Diuretic
Indications & Usage
Uses
Temporarily relieves headache, bloating, cramps, backache, water-weight gain, muscular aches and pains associated with the menstrual period.
Warnings
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
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
Ask a doctor before use if you have
■ liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if
■ you are taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose.
Otc - Stop Use
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
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 59°-86°F (15°-30°C)
■ avoid excessive heat and humidity
■ tamper-evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
D&C yellow #10, FD&C blue #1, FD&C red #40, microcrystalline cellulose,
povidone, starch, stearic acid, sucrose
Otc - Questions
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
* Please review the disclaimer below.
