ALMACONE- almacone liquid 
Rebel Distributors Corp

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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Almacone Drug Facts

Active ingredients

Aluminum Hydroxide 200mg

Magnesium Hydroxide 200mg

Keep Out of Reach of Children

Uses

Use(s)

Enter section text here

Uses relieves

• heartburn

• acid indigestion

• sour stomach

• gas associated with these conditions

Warnings

Ask a doctor before use if you have

• kidney disease

• a magnesium restricted diet

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

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

KEEP OUT OF REACH OF CHILDREN.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Directions

Shake well before use. Do not take more than 24 teaspoonful in 24 hours or use the maximum dosage for more than 2 weeks. Adults and children 12 years and older: take 2 to 4 teaspoonsfuls between meals, at bedtime, or as directed by a doctor.

Children under 12 years: ask a doctor.

Other Information

Each 5 mL teaspoon contains:

magnesium 25 mg, sodium 1 mg. Store at room temperature. Protect from freezing. Keep tighly closed.

Inactive ingredients

Benzoyl alcohol, butylparaben, carboxy methylcellulose sodium, flavor, hypromelloses, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution.

How Supplied

Almacone (antacid) is supplied in 12 oz. bottles NDC 21695-840-12

Questions or comments?

Call 1-800-645-2158, 9 am - 5 pm EST, Monday-Friday.

Distributed by:

Rugby Laboratories

Duluth, GA 30097

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Almacone (Antacid) 200mg/ 200mg/ 20mg

ALMACONE 
almacone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-840(NDC:0536-0025)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) MAGNESIUM HYDROXIDE200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-840-12355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/11/2008
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2011
Document Id: 25df52b1-c0b3-49ea-b97f-0763b64db011
Set id: 25df52b1-c0b3-49ea-b97f-0763b64db011
Version: 1
Effective Time: 20110215
 
Rebel Distributors Corp