ALUMINUM HYDROXIDE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)

Available from:

LLC Federal Solutions

INN (International Name):

ALUMINUM HYDROXIDE

Composition:

ALUMINUM HYDROXIDE 320 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Antacid Uses For the relief of - heartburn - acid indigestion - sour stomach Stop use and ask a doctor if symptoms last more than 2 weeks

Authorization status:

OTC monograph final

Summary of Product characteristics

ALUMINUM HYDROXIDE - ALUMINUM HYDROXIDE GEL
LLC FEDERAL SOLUTIONS
_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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ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
Aluminum hydroxide 320 mg
PURPOSE
Antacid
Uses
For the relief of
heartburn
acid indigestion
sour stomach
WARNINGS
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 you may get constipated
STOP USE AND ASK A DOCTOR IF symptoms last more than 2 weeks
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
DIRECTIONS
shake well before using
do not take more than 12 teaspoonfuls in 24 hours
do not use the maximum dosage for more than 2 weeks
DOSAGE: 2 teaspoonfuls 5-6 times daily after meals and at bedtime
followed by a sip of water if
needed
OTHER INFORMATION
store at room temperature
protect from freezing
keep tightly closed
INACTIVE INGREDIENTS
benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose,
propylparaben, purified water,
saccharin sodium, simethicone emulsion, sorbitol solution
QUESTIONS OR COMMENTS?
Call 1-855-333-6337
REPACKAGED BY:
Safecor Health LLC
317 New Boston St.
Woburn, MA 01801
Distributed by:
LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33123
———PRINCIPAL DISPLAY PANEL———
NDC: 24451-091-30
ALUMINUM HYDROXIDE
GEL, USP
1920 mg / 30 mL
DELIVERS 30 mL
SUGAR FREE
MINT FLAVOR
SHAKE WELL BEFORE USING
Exp: 00/00/00 Lot # 00000
Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132
ALUMINUM HYDROXIDE
aluminum hydroxide gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:24451-0 9 1(NDC:0 536 -0 0 9 1)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 ) (ALUMINUM HYDROXIDE -
UNII:5QB0 T2IUN0 )
ALUM