DUAL ACTION PEPCID COMPLETE- famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable tablet, chewable

DUAL ACTION Pepcid Complete by

Drug Labeling and Warnings

DUAL ACTION Pepcid Complete by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Famotidine 10 mg
Calcium carbonate 800 mg
Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

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
• kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacids and acid reducers 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 320 mg, magnesium 70 mg
• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20° - 25°C (68° - 77°F)
• protect from moisture
• do not use if pouch is torn or damaged

Inactive Ingredients

cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose

Questions or Comments?

1-800-755-4008 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA

©McNeil Consumer Pharmaceuticals Co. 2022 US Patent Nos. 6,814,978

Repackaged with permission of manufacturer by:

Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

Distributed by: Consumer Value Products, Inc., Temple, TX 76502

www.CVPproducts.com

CVP 2 Count Carton

DUAL ACTION

Pepcid ®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

CVP

HEALTH

INGREDIENTS AND APPEARANCE

DUAL ACTION PEPCID COMPLETE 
famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-6522
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) (CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	165 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ACACIA (UNII: 5C5403N26O)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ALUMINUM OXIDE (UNII: LMI26O6933)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
CROSPOVIDONE (UNII: 2S7830E561)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	18mm
Flavor	BERRY	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-6522-2	2 in 1 CARTON	07/29/2020
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020958	07/29/2020

Labeler - Lil' Drug Store Products, Inc. (093103646)