SPL v1
SPL
SPL Set ID af9b799f-69c5-401c-9c43-a97b23384cc2
Route
ORAL
Published
Effective Date 2013-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (320 mg)
Inactive Ingredients
Benzyl Alcohol Butylparaben Glycerin Hydroxyethyl Cellulose (4000 Mpa.s At 1%) Propylparaben Water Saccharin Sodium Dihydrate Dimethicone Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-08-12

Description

Active ingredient (in each 5 mL teaspoonful) Aluminum hydroxide 320 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

For the relief of

  • heartburn
  • acid indigestion
  • sour stomach
Dosage and Administration

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
Description

Active ingredient (in each 5 mL teaspoonful) Aluminum hydroxide 320 mg

Section 42229-5

Repackaged by:

Safecor Health LLC

317 New Boston St.

Woburn, MA 01801

Distributed by:

LLC Federal Solutions

14 NE 1st Ave.

Miami, FL 33123

Section 50565-1

Keep this and all drugs out of reach of children.

Section 50566-9

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

Section 50567-7

When using this product you may get constipated

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

Section 51727-6

Inactive ingredients

benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution

Section 51945-4





———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

Section 53413-1

Questions or comments?

Call 1-855-333-6337

Section 55105-1

Purpose

Antacid

Section 55106-9

Active ingredient (in each 5 mL teaspoonful)

Aluminum hydroxide 320 mg

Section 60561-8

Other information

  • store at room temperature
  • protect from freezing
  • keep tightly closed

Structured Label Content

Indications and Usage (34067-9)

Uses

For the relief of

  • heartburn
  • acid indigestion
  • sour stomach
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Repackaged by:

Safecor Health LLC

317 New Boston St.

Woburn, MA 01801

Distributed by:

LLC Federal Solutions

14 NE 1st Ave.

Miami, FL 33123

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product you may get constipated

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

Section 51727-6 (51727-6)

Inactive ingredients

benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution

Section 51945-4 (51945-4)





———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

Section 53413-1 (53413-1)

Questions or comments?

Call 1-855-333-6337

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL teaspoonful)

Aluminum hydroxide 320 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature
  • protect from freezing
  • keep tightly closed

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)