DUAL ACTION COMPLETE- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable 
Publix Super Markets Inc

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Publix Super Markets, Inc. Dual Action Complete Drug Facts

Active ingredients (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purposes

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
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 330 mg; magnesium 80 mg
Phenylketonurics: Contains Phenylalanine 2 mg per tablet
read the directions and warnings before use
read the bottle. It contains important information.
store at 68-77°F (20-25°C)
protect from moisture

Inactive ingredients

anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Package/Label Principal Display Panel

SEE NEW WARNINGS

BERRY FLAVOR

dual action complete

FAMOTIDINE 10 mg/CALCIUM CARBONATE 800 mg/MAGNESIUM HYDROXIDE 165 mg TABLETS (CHEWABLE)

ACID REDUCER + ANTACID

Just one tablet relieves heartburn due to acid indigestion

ACTUAL SIZE

Compare to active ingredients in Pepcid Complete®

25 CHEWABLE TABLETS

321-63-dual-action-complete.jpg
DUAL ACTION COMPLETE 
famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-263
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ASPARTAME (UNII: Z0H242BBR1)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
DEXTRATES (UNII: G263MI44RU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINK (mottled) Scoreno score
ShapeROUND (bi-layered) Size17mm
FlavorBERRYImprint Code L321
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-263-6325 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2018
2NDC:56062-263-7150 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735511/06/2018
Labeler - Publix Super Markets Inc (006922009)

Revised: 11/2021
Document Id: 2cbd5f8b-af85-4081-a6d4-7d998ad2a16e
Set id: 913073fe-22ce-40a3-ad22-bf3027c21e99
Version: 4
Effective Time: 20211109
 
Publix Super Markets Inc