LDR ES heartburn relief

LDR ES heartburn relief

Drug Labeling and Warnings

Drug Details

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EXTRA STRENGTH HEARTBURN RELIEF- aluminum hydroxide and magnesium carbonate suspension 
CARDINAL HEALTH

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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LDR ES heartburn relief

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 254 mg
Magnesium carbonate 237.5 mg

Purpose

Antacid

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Warnings

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet
  • a sodium-restricted diet

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

When using this product

  • laxative effect may occur
  • do not use maximum dosage for more than 2 weeks
  • do not take more than 16 teaspoonfuls in 24 hours

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

Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away

Directions

  • shake well before use
  • adults and children 12 years and older take 2-4 teaspoonsful four times a day or as directed by a doctor
  • children under 12 years: consult a doctor
  • take after meals and at bedtime
  • dispense product only by spoon or other measuring device

Other information

  • each 5 mL teaspoonful contains: magnesium 70 mg, sodium 16 mg
  • store at room temperature
  • protect from freezing
  • keep tightly closed
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is broken or missing.

Inactive ingredients

benzyl alcohol, edetate disodium, flavor, glycerin, purified water, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, xanthan gum

Questions or comments?

1-800-540-3765

package Label

1

EXTRA STRENGTH HEARTBURN RELIEF 
aluminum hydroxide and magnesium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0363
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE254 mg  in 5 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE237.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-0363-1355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/01/2019
Labeler - CARDINAL HEALTH (097537435)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861manufacture(70000-0363)

Revised: 1/2019
 
CARDINAL HEALTH


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