MINTOX MAXIMUM STRENGTH - aluminum hydroxide, magnesium hydroxide, dimethicone suspension 
Atlantic Biologicals Corps

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

Purposes

Antacid

Antigas

Uses

relieves

Warnings

Ask a doctor before use if you have

• kidney disease

• a magnesium-restricted diet

taking a prescription drug. Ask a doctor or pharmacist before use if you are

Antacids may interact with certain prescription drugs.

symptoms last more than 2 weeks Stop use and ask a doctor if

ask a health professional before use. If pregnant or breast-feeding,

Keep out of reach of children.

Directions

• shake well before use

• do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor

• children under 12 years: ask a doctor

Other information

• magnesium 165 mg, sodium 1 mg each 5 mL teaspoonful contains:

• store at room temperature

• protect from freezing

 • keep tightly closed

TAMPER-EVIDENT: Do not use if breakaway band on bottle cap is missing or broken.

Inactive ingredients

benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10,  flavor, glycerin, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION

image description
MINTOX MAXIMUM STRENGTH  
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5725(NDC:0904-5725)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-5725-115 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
2NDC:17856-5725-330 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/01/2011
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-5725) , REPACK(17856-5725)

Revised: 1/2021
Document Id: 0718fa1d-fe2b-486b-a504-3e25ac820e63
Set id: ac6a47e7-972f-4b82-96da-89926d345e9f
Version: 6
Effective Time: 20210128
 
Atlantic Biologicals Corps