Label: COMPLETE- famotidine, magnesium hydroxide and calcium carbonate tablet, chewable
- NDC Code(s): 59779-673-63, 59779-673-71, 59779-673-98
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 ingredients (in each chewable tablet)
Famotidine 10 mg
Calcium carbonate 800 mg
Magnesium hydroxide 165 mgClose
relieves heartburn associated with acid indigestion and sour stomachClose
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
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)
- 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
- Phenylketonurics: Contains phenylalanine 2.2 mg per tablet
- 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, 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, talcClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredients in Pepcid Complete®
FAMOTIDINE 10 mg/CALCIUM CARBONATE 800 mg
MAGNESIUM HYDROXIDE 165 mg TABLETS
Acid Reducer plus Antacid
Just one tablet
Relieves heartburn due to acid indigestion
50 CHEWABLE TABLETS
- INGREDIENTS AND APPEARANCE
famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-673 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 165 mg CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 800 mg Inactive Ingredients Ingredient Name Strength ASPARTAME DEXTRATES GLYCERYL MONOSTEARATE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYSORBATE 80 POVIDONES TALC Product Characteristics Color PINK (mottled) Score no score Shape ROUND (bi-layered) Size 17mm Flavor BERRY Imprint Code L321 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-673-63 25 in 1 BOTTLE 2 NDC:59779-673-71 50 in 1 BOTTLE 3 NDC:59779-673-98 75 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077355 08/05/2008 Labeler - CVS Pharmacy (062312574)