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NDC 00132-0195-12 Pedia-Lax 2.8 g/4mL Details
Pedia-Lax 2.8 g/4mL
Pedia-Lax is a RECTAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is GLYCERIN.
Product Information
| NDC | 00132-0195 |
|---|---|
| Product ID | 0132-0195_2db5157b-2ca6-4160-bbf6-8fd37ba8bef5 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Pedia-Lax |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Glycerin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | RECTAL |
| Active Ingredient Strength | 2.8 |
| Active Ingredient Units | g/4mL |
| Substance Name | GLYCERIN |
| Labeler Name | C.B. Fleet Company, Inc. |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00132-0195-12 (00132019512)
| NDC Package Code | 0132-0195-12 |
|---|---|
| Billing NDC | 00132019512 |
| Package | 6 APPLICATOR in 1 CARTON (0132-0195-12) / 4 mL in 1 APPLICATOR |
| Marketing Start Date | 2019-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ae367381-7146-4307-823d-2bb44c1d4200 Details
Uses
Warnings
For rectal use only
May cause rectal discomfort or a burning sensation.
Ask a doctor before using any laxative if the child has
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
- if constipation continues after one week of use, contact your child's doctor
Directions
Single Daily Dosage (per 24 hours)
children 2 to under 6 years: one suppository per day or as directed by a doctor
children under 2 years: consult a doctor
Administering the laxative:
CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING. Hold unit upright, grasping bulb of unit with fingers. Grasp orange protective shield with other hand, pull gently to remove. With steady pressure, gently insert tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Discontinue use if resistance is encountered. Forcing the tip can result in injury. Insertion may be easier if child receiving suppository bears down as if having a bowel movement. This helps relax the muscles around the anus. Squeeze the bulb until nearly all liquid is expelled. While continuing to squeeze the bulb, remove tip from rectum and discard unit. It is not necessary to empty unit completely. The unit contains more than the amount of liquid needed for effective use. A small amount of liquid will remain in the unit after squeezing.
Left-side position: Place child on left side with knees bent and arms resting comfortably.
Knee-chest position: Have child kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.
Other information
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| PEDIA-LAX
glycerin liquid |
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| Labeler - C.B. Fleet Company, Inc. (003119054) |