Você está na página 1de 4

ANTACID MINT - aluminum hydroxide, magnes ium hydroxide, dimethicone s us pens ion

Chain Drug Marketing As s ociation


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.
----------

Active ingredients (in each 5 mL teas poonful)


Aluminum hydroxide 200 mg (equivalent to dried gel, USP)
Magnesium hydroxide 200 mg
Simethicone 20mg

Purpos es
Antacid
Antigas

Us es
relieves
heartburn
sour stomach
acid indigestion
the symptoms referred to as gas

Warnings
As k a doctor before us e if you have
• kidney disease
• a magnesium-restricted diet

As k a doctor or pharmacis t before us e if you are taking a prescription drug.


Antacids may interact with certain prescription drugs.
Stop us e and as k a doctor if symptoms last more than 2 weeks
If pregnant or breas t-feeding, ask a health professional before use.
Keep out of reach of children.

Directions
• shake well before each use
• adults and children 12 years and older: take 2 to 4 teaspoonfuls, as needed, up to four times a day, or as
directed by a doctor
• do not take more than 16 teaspoonfuls in 24 hours unless directed by a doctor or use the maximum
dosage for more than 2 weeks
• children under 12 years: ask a doctor
Other information
• each 5 mL teas poonful contains : magnesium 85 mg, sodium 1 mg
• store at room temperature
• protect from freezing
• keep tightly closed

Inactive ingredients
benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline
cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

package Label
NDC 63868-694-57
QUALITY CHOICE
*Compare to the Active Ingredients in MAALOX Regular Strength
Regular Strength
Antacid
Suspension
antacid and antigas
Alumina, Magnesia and Simethicone Oral Suspension USP
Fast Relief of:
ACID INDIGESTION
HEARTBURN
SOUR STOMACH
PRESSURE AND BLOATING
Cool Mint
Flavored Liquid
12 FL OZ (355 mL)
ANTACID MINT
aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Product Information
Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:6 38 6 8 -6 9 4

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety


Basis o f
Ing redient Name Streng th
Streng th
ALUMINUM 20 0 mg
ALUMINUM HYDRO XIDE (UNII: 5Q B0 T2IUN0 ) (ALUMINUM HYDRO XIDE - UNII:5Q B0 T2IUN0 )
HYDRO XIDE in 5 mL
MAGNESIUM HYDRO XIDE (UNII: NBZ3Q Y0 0 4S) (MAGNESIUM CATIO N - UNII:T6 V3LHY8 38 , MAGNESIUM 20 0 mg
HYDRO XIDE IO N - UNII:9 159 UV38 1P) HYDRO XIDE in 5 mL
20 mg
DIMETHICO NE (UNII: 9 2RU3N3Y1O ) (DIMETHICO NE - UNII:9 2RU3N3Y1O ) DIMETHICO NE
in 5 mL
Inactive Ing redients
Ing redient Name Streng th
BENZYL ALCO HO L (UNII: LKG8 49 4WBH)
BUTYLPARABEN (UNII: 3Q PI1U3FV8 )
CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 O BS311)
HYPRO MELLO SES (UNII: 3NXW29 V3WO )
CELLULO SE, MICRO CRYSTALLINE (UNII: O P1R32D6 1U)
PRO PYLPARABEN (UNII: Z8 IX2SC1O H)
WATER (UNII: 0 59 Q F0 KO 0 R)
SACCHARIN SO DIUM DIHYDRATE (UNII: SB8 ZUX40 TY)
SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics
Color S core
S hap e S iz e
Flavor MINT Imp rint Cod e
Contains

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:6 38 6 8 -6 9 4-57 355 mL in 1 BO TTLE

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
O TC mo no gra ph fina l pa rt331 0 3/0 1/20 14

Labeler - Chain Drug Marketing As s ociation (011920774)

Registrant - GCP Laboratories (965480861)

Establishment
Name Ad d re s s ID/FEI Bus ine s s Op e rations
GCP La bo ra to rie s 9 6 548 0 8 6 1 ma nufa c ture (6 38 6 8 -6 9 4)

Revised: 7/2014 Chain Drug Marketing Association