FDA Label for Glycerin Children

View Indications, Usage & Precautions

Glycerin Children Product Label

The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. 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.

Otc - Active Ingredient



Active ingredient (in each suppository)

Glycerin USP, 1.2 grams


Otc - Purpose



Purpose

Laxative


Warnings



Warnings

For rectal use only


Otc - Ask Doctor



Ask a doctor before use if the child has

  • stomach 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 child has

  • rectal bleeding
  • no bowel movement after using this product
  • These may indicate a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.


Inactive Ingredient



Inactive ingredients purified water, sodium stearate


Otc - Questions



Questions or Comments? Call 1-844-474-7464


Package Label.Principal Display Panel



NDC 57237-326-52 (5 blisters of 5 suppositories)

Children's Glycerin Suppositories 1.2 g

LAXATIVE

For fast, gentle relief of occasional constipation

For ages 2 to 5 years

NDC 57237-326-51 (5 suppositories in 1 blister pack)

Front Foil

Back Foil


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