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  5. Label Information: Stratuscare Adult Glycerin

FDA Label for Stratuscare Adult Glycerin

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (PER SUPPOSITORY)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - DO NOT USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 50 SUPPOSITORY JAR LABEL

Stratuscare Adult Glycerin Product Label

The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186


Active Ingredient (Per Suppository)



Glycerin, USP 2 g


Purpose



Laxative


Use



  • For relief of occasional constipation (irregularity)
  • generally produces bowel movement in ¼ to 1 hour.

Warnings



For rectal use only.

May cause rectal discomfort or burning sensation.


Otc - Ask Doctor



Ask a doctor before use if you have:

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks.

Otc - Stop Use



Stop use and ask a doctor:

  • if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Otc - Do Not Use



  • Do not use laxative products for longer than 1 week unless directed by a doctor

Otc - Pregnancy Or Breast Feeding



  • If pregnant or breastfeeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).


Directions



  • Adults and children 6 years and over:
    • Carefully insert one suppository well into rectum
    • It need not melt completely to produce laxative action
    • Generally produces bowel movement in 15 minutes to 1 hour
    • Do not exceed one suppository daily unless directed by a doctor
    • Children under 6 years old: do not use

Other Information



  • Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)
  • Keep container tightly closed

Inactive Ingredients



purified water, sodium stearate


Questions Or Comments?



1-800-442-7882


Principal Display Panel - 50 Suppository Jar Label



NDC 58980-410-50

STRATUSCARE

ADULT

Glycerin
Suppositories
Laxative

Distributed by:
STRATUS
PHARMACEUTICALS INC

DO NOT USE IF INNER SEAL IS BROKEN OR MISSING.

50 SUPPOSITORIES

Principal Display Panel - 50 Suppository Jar Label - stratuscare 01

Principal Display Panel - 50 Suppository Jar Label - stratuscare 01


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