Pure and Gentle Laxative

Manufacturer
Medline Industries, LP
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:39:29

Label at a glance#

ProductPure and Gentle Laxative
Active ingredientSODIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, MONOBASIC
Label structure10 sections

Indications and uses

relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes

Dosage and administration

(or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings. adults & children 12 years and over 1 bottle once daily children 2 to under 12 years Use Pediatric Enema children under 2 years DO NOT USE CAUTION: Remove protective shield from enema tip before inserting. Hold bottle upright, grasping bot...

Storage and handling

each 118 mL contains sodium 4.3 g store at15-30°C (59-86°F) additional liquids by mouth are recommended while using this product Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes

Warnings

WARNINGS SECTION

Dosage warning: Using more than one enema in 24 hours can be harmful.

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away: 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

(or as directed by a doctor)

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings.

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

Use Pediatric Enema

children under

2 years

DO NOT USE

CAUTION:Remove protective shield from enema tip before inserting.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

Remove protective shield illustrationRemove protective shield illustration

Positions for using this enema:

Left-side position: lie on left side with knee bent and arms at rest.

Left Side position illustrationLeft Side position illustration

Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

Knee-chest position illustrationKnee-chest position illustration

Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side to side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. Doing so helps relax muscles around anus.
  • Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty unit completely, as it containsmore liquid than needed.
  • Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Directions

RECENT MAJOR CHANGES SECTION

(or as directed by a doctor)

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings

Adults and children 12 years old and older1 bottle once daily
Children 2 to under 12 years oldUse Pediatric Enema
Children under 2 yearsDO NOT USE

CAUTION: Remove protective shield from enema tip before inserting.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

image 1image 1

Positions for using this enema:

Left-side position:
Lie on left side with knees bent and arms resting comfortably.

image 2image 2

Knee-chest position:
Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

image 3image 3

Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. Doing so helps relax muscles around anus.
  • Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty bottle completely, as it contains more liquid than needed.
  • Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other Information

STORAGE AND HANDLING SECTION

  • each 118 mL contains sodium 4.3 g
  • store at15-30°C (59-86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

OTC - QUESTIONS SECTION

866-323-0107

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: CUR095005

V1 RD22NPX

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label PDPLabel PDP

Label V1 RD22NPXLabel V1 RD22NPX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN13
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD13
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY13
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY13

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-014-11Pure and Gentle Laxative1 in 1 BOXENEMA113
53329-014-11Pure and Gentle Laxative133 mL in 1 BOTTLEENEMA13313
53329-014-58Pure and Gentle Laxative133 mL in 1 BOTTLEENEMA13313
53329-014-58Pure and Gentle Laxative24 in 1 CASEENEMA2413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-014PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, LP]13Current NDC, Legacy NDC, 4 package rows20241127_e3165538-75dd-4f0f-adc8-d4075de10f1e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-014-11ML - Milliliter53329-014880b0529-6881-4d11-8446-2e878878af3d12018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM PHOSPHATE, DIBASICACTIVE INGREDIENTGR686LBA743
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SW3
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W73
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-01453329-014-11, 53329-014-58

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 75 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
72 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
72 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
72 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
ndc (package): 53329-014-58
ndc (package): 53329-014-11
ndc (product): 53329-014
ndc11 (package): 53329001411
ndc11 (package): 53329001458
spl id: 27d44bbd-bd6d-844e-e063-6394a90a6273
spl set id: e3165538-75dd-4f0f-adc8-d4075de10f1e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.