Active Ingredients
Aluminum Hydroxide 200mg
Magnesium Hydroxide 200mg
Almacone
FDA Label NDC 21695-840
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Almacone (NDC 21695-840). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warnings, directions, other information, inactive ingredients, how supplied, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (25df52b1 C0b3 49ea B97f 0763b64db011 01)
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