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Name:Almacone
Manufacturer:Rebel Distributors Corp
Category:Over-the-counter (OTC) Marketed Drugs


Almacone Drug Facts

ALMACONE - aluminum hydroxide and magnesium hydroxide 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 Type HUMAN OTC DRUG Item Code (Source) NDC:21695-840(NDC:0536-0025)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 200 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
BUTYLPARABEN  
CELLULOSE, MICROCRYSTALLINE  
CARBOXYMETHYLCELLULOSE  
HYPROMELLOSES  
PROPYLPARABEN  
WATER  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-840-12 355 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 11/11/2008

Labeler - Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 02/2011 Rebel Distributors Corp



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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