Label: GREEN GUARD CRAMP RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

  • NDC Code(s): 47682-049-47, 47682-049-80, 47682-049-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 19, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Acetaminophen 500 mg

    Pamabrom 25 mg

    Pyrilamine maleate 15 mg

  • PURPOSE

    Purpose

    Pain reliever

    Diuretic

    Antihistamine

  • INDICATIONS & USAGE

    Uses

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

    ■ headache

    ■ bloating

    ■ cramps

    ■ backache

    ■ muscular aches

    ■ irritability

    ■ water-weight gain

  • WARNINGS

    Warnigs

    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.

  • 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.

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

  • ASK DOCTOR

    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

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ■ taking sedatives or tranquilizers

    ■ taking the blood thinning drug warfarin

  • WHEN USING

    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

  • STOP USE

    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.

  • 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 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

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

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    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

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • PRINCIPAL DISPLAY PANEL

    Menstrual Cramp Relief™

    Pull to Open

    Tire Para Abrir

    Acetaminophen 500 mg / Acetaminofeno 500 mg

    Pamabrom 25 mg

    Pyrilamine maleate 15 mg / Maleato de pirilamina 15 mg

    Green Guard®

    Relief of menstrual pain, water retention and bloating

    Para el alivio de dolores menstruales,

    retencion de liquidos e hinchazon

    40 Packets of 2 Caplets

    80 Caplets

    Order #2380

    Distributed by Green Guard®

    St Louis, MO 63045

    Green Guard

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD CRAMP RELIEF 
    acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code 44;679
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-049-8040 in 1 BOX09/26/2022
    1NDC:47682-049-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-049-47100 in 1 BOX09/26/2022
    2NDC:47682-049-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02709/26/2022
    Labeler - Unifirst First Aid Corporation (832947092)