WESTERN FAMILY (SALINE LAXATIVE) ENEMA [WESTERN FAMILY HOLDING COMPANY]

WESTERN FAMILY (SALINE LAXATIVE) ENEMA [WESTERN FAMILY HOLDING COMPANY]
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NDC 55312-111-11, 55312-111-35
Set ID 2decb9d1-1ebc-438c-8a72-c5363607ab7e
Category HUMAN OTC DRUG LABEL
Packager WESTERN FAMILY HOLDING COMPANY
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredients (in each 118 mL delivered dose)

    Dibasic sodium phosphate 7 g

    Monobasic sodium phosphate 19 g

  • Purpose

    Saline laxative

  • Uses

    relieves occasional constipation
  • Warnings

    For rectal use only

    Dosage warning: Using more than one enema in 24 hours can be harmful.

    Ask a doctor before use if you have

    a sodium-restricted diet
    abdominal pain, nausea or vomiting
    kidney disease, heart problems, or are dehydrated
    noticed a sudden change in bowel habits that lasts over 2 weeks

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    When using this product

    do not use more than directed. Serious side effects may occur from excess dosage.
    do not use for more than 3 days

    Stop use and ask a doctor if

    you have rectal bleeding
    you have no bowel movement after use of a laxative

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    Do not use more unless directed by a doctor. See Warnings.

    adults & children 12 years and over

    one bottle once daily

    children 2 to under 12 years

    ½ bottle once daily

    Discard unused portion

    children under 2 years

    do not use

    Caution:

    REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.

    Hand Positioning

    Positioning:

    Left-side position: Lie on left side with knee bent and arms at rest.

    Left side position

    Knee-chest position:

    Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

    Knee Chest Position

    Administering enema:

     With steady pressure, gently insert enema with tip pointing toward navel
    squeeze bottle until recommended dose is expelled (it is not necessary to empty until completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
    Remove tip from rectum.
    stop using if tip is hard to insert. Forcing the tip into rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
    maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
    if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
  • Other information

    each 118 mL contains: sodium 4.3 g
    store at room temperature 20º-25ºC (68º-77ºF)
    this product generally produces bowel movement in 1 to 5 minutes
  • Inactive ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions or comments?

    1-800-633-5463

  • Package Label 1 - Principal Display Panel

    Western Family

    Ready-to-use

    Enema

    Saline Laxative

    For relief of

    Occasional Constipation

    Soft, Flexible

    Comfort Tip

    Latex Free

     
    4.5 FL OZ (133 mL)
     
    Compare to Fleet Enema Saline active ingredients*
     
    Western Family Saline Laxative PDP
  • Package Label - Back and Side Label with Drug Facts

    Western Family Saline Laxative Drug Facts
  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY 
    saline laxative enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-111
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-111-111 in 1 CARTON
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55312-111-352 in 1 CARTON
    2133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/16/2013
    Labeler - WESTERN FAMILY HOLDING COMPANY (192166072)

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