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NDC 36800-0616-71 topcare dual action complete 800; 10; 165 mg/1; mg/1; mg/1 Details
topcare dual action complete 800; 10; 165 mg/1; mg/1; mg/1
topcare dual action complete is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE.
MedlinePlus Drug Summary
Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 36800-0616-71Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Calcium Carbonate
Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.
Related Packages: 36800-0616-71Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Famotidine
Magnesium hydroxide is used to treat occasional constipation in children and adults on a short-term basis. Magnesium hydroxide is in a class of medications called saline laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.
Related Packages: 36800-0616-71Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Magnesium Hydroxide
Product Information
| NDC | 36800-0616 |
|---|---|
| Product ID | 36800-616_967e727c-731d-49b9-a6a0-5303597a6068 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | topcare dual action complete |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | famotidine, calcium carbonate and magnesium hydroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 800; 10; 165 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Elect |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077355 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0616-71 (36800061671)
| NDC Package Code | 36800-616-71 |
|---|---|
| Billing NDC | 36800061671 |
| Package | 50 TABLET, CHEWABLE in 1 BOTTLE (36800-616-71) |
| Marketing Start Date | 2016-02-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8ef70327-9a04-413b-b331-f5d3a94d6b36 Details
Active ingredients (in each chewable tablet)
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.
Directions
Other information
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
Principal Display Panel
INGREDIENTS AND APPEARANCE
| TOPCARE DUAL ACTION COMPLETE
famotidine, calcium carbonate and magnesium hydroxide tablet, chewable |
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| Labeler - Topco Associates LLC (006935977) |