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| Product NDC Code | 17433-9884 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusol kids |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1486983, 1486985 |
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| Application Number | part334 | ||||
| Labeler Name | Enemeez LLC DBA Summit Pharmaceuticals | ||||
| 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.Drug Facts Active Ingredient (per delivered dose) Docusate Sodium USP 100 mg
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 Children 2 years to under 12 years of age (with adult supervision) one unit daily. Children under 2 years of age, consult a doctor prior to use. Twist off and remove tip. Lubricate tip prior to insertion: Place a few drops of the tube's liquid content on the shaft prior to insertion. Also apply liquid content or lubricant to the anus before inserting the mini-enema. Positioning: For best results, lay on the left side with knees bent. Alternate Positions: Administer while seated on the toilet. Or, kneel, then lower head and chest forward until side of face is resting on the surface. With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall. Insert up to shoulder of tube. Squeeze to empty the contents. Keep the tube squeezed until it is removed from the rectum. After the contents have been emptied, remove the disposable tube and discard. A small amount of liquid may remain in the unit after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin USP and Polyethylene Glycol
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 (irregularity). This product generally produces a bowel movement in 2 to 15 minutes.
Purpose
Information about the drug product’s indications for use.Purpose Stool Softener Laxative
Spl product data elements
Usually a list of ingredients in a drug product.DocuSol Kids docusate sodium POLYETHYLENE GLYCOL 300 GLYCERIN DOCUSATE SODIUM DOCUSATE
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.9884-5 pdp
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Laxative products when abdominal pain, nausea or vomiting are present. Laxative products for a period longer than 1 week unless directed by a 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 In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at room temperature 15° - 30° C (59° - 86° F)
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 use and ask a doctor if you have: Rectal bleeding. Noticed a sudden change in bowel habits that persists over a period of 2 weeks. Failed to have a bowel movement after use. This may indicate a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnant or Lactating Women Ask a health professional before use.
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. Drug Interaction Precaution: Do not take this product if you are presently taking mineral oil, unless directed by a doctor.
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