Label: UNISHIELD CRAMP- acetaminophen, pamabrom tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 16, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 325 mg

    Pamabrom 25 mg

  • 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.

  • 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

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if

    ■ you are taking the blood thinning drug warfarin

  • WHEN USING

    When using this product do not exceed recommended dose.

  • 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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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 59º-86ºF (15º-30ºC)

    ■ 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

  • 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

    810

  • INGREDIENTS AND APPEARANCE
    UNISHIELD CRAMP 
    acetaminophen, pamabrom tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-8103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SUCROSE (UNII: C151H8M554)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (red and green crystals) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR;7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-8103-350 in 1 BOX03/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)