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| Product NDC Code | 0132-0195 | ||||
|---|---|---|---|---|---|
| Drug Name | Pedia-lax |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 895966, 1190433 |
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| Application Number | part334 | ||||
| Labeler Name | C.B. Fleet Company, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 2.7 mL average delivered dose) Glycerin 2.8 g
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients edetate disodium, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for relief of occasional constipation this product generally produces bowel movement in 1/4 to 1 hour
Purpose
Information about the drug product’s indications for use.Purpose Hyperosmotic laxative
Spl product data elements
Usually a list of ingredients in a drug product.Pedia-Lax Glycerin GLYCERIN GLYCERIN EDETATE DISODIUM WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Baby Care Pedia -Lax ® Liquid glycerin suppositories rectal laxative 6 applicators (4 ml each) PRINCIPAL DISPLAY PANEL Baby Care Pedia-Lax ® Liquid glycerin suppositories rectal laxative 6 applicators (4 ml each)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information carton sealed for safety. If seal with Fleet emblem on bottom flap or top flap is broken or missing, do not use.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-255-6960 or www.pedia-lax.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop using this product and consult a doctor if the child has rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Stop using this product and consult a doctor if the child has rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API