Pure and Gentle Laxative

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Pure and Gentle Laxative
Generic name
SODIUM PHOSPHATE
Manufacturer
Medline Industries, LP
Product type
HUMAN OTC DRUG
SPL set ID
e3165538-75dd-4f0f-adc8-d4075de10f1e
SPL ID
27d44bbd-bd6d-844e-e063-6394a90a6273
Version
13
Effective date
2024-11-26
Source export date
2026-08-08
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/c371bcf53af83126908f941c4bb6f83aeaa6e2ef3749f9f7be6c7a3681e3b333/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:23:27
Harmonized routes table
Harmonized routes
RECTAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Dosage warning: Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use on children under 2 years of age Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea or vomiting have a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal) These symptoms may indicate a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 1-800-222-1222.