LEADER ACID REDUCER COMPLETE- famotidine, calcium carbonate, magnesium hydroxide tablet, chewable

leader acid reducer complete by

Drug Labeling and Warnings

leader acid reducer complete by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Use

relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• with other acid reducers

Ask a doctor before use if you have

• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating, or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days

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 (1-800-222-1222).

Directions

• adults and children 12 years and over:
• do not swallow tablet whole: chew completely
• to relieve symptoms, chew 1 tablet before swallowing
• do not use more than 2 chewable tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• each tablet contains: calcium 335 mg; magnesium 80 mg
• read the directions and warnings before use
• read the bottle label. It contains important information.
• store at 20-25°C (68-77°F)
• protect from moisture

Inactive ingredients

anhydrous lactose, crospovidone, D&C yellow #10 aluminum lake, ethylcellulose aqueous dispersion, FD&C blue #1 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, mannitol, mineral oil, natural and artificial cool mint flavor, polysorbate 80, sodium metabisulfite, sucralose, talc, triethyl citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Dual Action

Acid Reducer Complete

Famotidine, Calcium Carbonate and Magnesium Hydroxide Chewable Tablets 10mg/800mg/165mg

Acid Reducer plus Antacid

Cool Mint Flavor

Just One Tablet Relieves Heartburn Due to Acid Indigestion

COMPARE TO PEPCID COMPLETE® active ingredients

Actual Size

100% Money Back Guarantee

25 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

LEADER ACID REDUCER COMPLETE 
famotidine, calcium carbonate, magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0316
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	165 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
ISOMALT (UNII: S870P55O2W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	GREEN (mottled green & white) ,	Score	no score
Shape	ROUND	Size	17mm
Flavor	MINT	Imprint Code	Plus
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0316-1	25 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204782	01/15/2020

Labeler - Cardinal Health (097537435)