Label: PEDIATRIC GLYCERIN LAXATIVE - glycerin suppository
- NDC Code(s): 49781-080-25
- Packager: Cardinal Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Drug Facts Active ingredient
Glycerin, USP 1 g
- Keep out of reach of children.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).Close
For relief of occasional constipationClose
For rectal use only. May cause rectal discomfort or burning sensation.Close
- Ask a doctor before use if your child has
- abdominal pain,nausea,or vomiting.
- a sudden change in bowel habits lasting more than 2 weeks.
- if you have already used a laxative for a week
- Stop use and ask a doctor if your child has
rectal bleeding or fails to have a bowel movement within one hour of using this product.Close
This may indicate a serious condition.
- If pregnant or breastfeeding,
ask a doctor before use.Close
- Children 2 to under 6 years:
- detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:
- hold suppository with pointed end up
- carefully separate tabs with fingernail
- slowly pull apart by pulling tabs down on both sides
- remove suppository from wrapper
- Carefully insert one suppository well into the rectum and retain for 15 minutes
- 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 2 years: consult a doctor
- Inactive ingredients
sodium stearate, purified waterClose
- Other information
- Store container tightly closed
- Keep from excessive heat
- Pediatric Glycerin Suppository Label
Compare to Fleet® active ingredient*
Pediatric Glycerin Suppositories
25 Pediatric Size
TAMPER-EVIDENT: FOR YOUR SAFETY , SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER. DO NOT USE IF WRAPPER IS TORN OR OPEN
E-Z Open Wrapper
Distributed by Cardinal Health, Inc.
Dublin, Ohio 43017
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
This product is not manufactured or distributed by C.B. Fleet Co. Inc., owner of the registered trademark Fleet®.
- INGREDIENTS AND APPEARANCE
PEDIATRIC GLYCERIN LAXATIVE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-080 Route of Administration RECTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g Inactive Ingredients Ingredient Name Strength SODIUM STEARATE (UNII: QU7E2XA9TG) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-080-25 25 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/01/2014 Labeler - Cardinal Health, Inc. (097537435) Registrant - Acino Products LLC (019385518) Establishment Name Address ID/FEI Business Operations Acino Products LLC 019385518 manufacture(49781-080)