Kesin MAG-AL Plus XS

Product NDC
81033-007
11-digit product format
810330007
Labeler code
81033
Product ID
81033-007_515185f7-687b-8010-e063-6394a90a1439
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum and Magnesium Hydroxide w/Simethicone Suspension
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-05
Substance
ALUMINUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; MAGNESIUM HYDROXIDE
Active strength
400; 40; 400 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kesin MAG-AL Plus XSALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b89f7-e417-0df2-e063-6394a90a96df2026-05-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not take more than 16 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician. Ask a doctor before use if you have kidney disease a magnesium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Kesin MAG-AL Plus XS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED400 mg/5mL
ALUMINUM HYDROXIDE40 mg/5mL
MAGNESIUM HYDROXIDE400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 5QB0T2IUN0, NBZ3QY004S
Rxcui237870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-007-01Kesin MAG-AL Plus XS100 in 1 CASESUSPENSION1002
81033-007-30Kesin MAG-AL Plus XS30 mL in 1 CUP, UNIT-DOSESUSPENSION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-007-01ML - Milliliter81033-0077f5cd877-bcb1-4b0e-b894-0f33117cca6512026-01-08
81033-007-30ML - Milliliter81033-00734c829f7-a155-482a-b4fe-2a9d451a705012026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY436b89f7-e417-0df2-e063-6394a90a96df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-007-0181033000701100 CUP, UNIT-DOSE in 1 CASE (81033-007-01) / 30 mL in 1 CUP, UNIT-DOSE (81033-007-30) 2025-11-05NoNoCurrent
81033-007-308103300073030 mL in 1 CUP, UNIT-DOSE30 mlHistorical