Ibuprofen and Famotidine (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Ibuprofen and famotidine tablets 800 mg/26.6 mg, are light blue to blue oval shaped, film coated tablets imprinted with ”IF826” in black on one side and plain on other side.

NDC: 63629-8891-1: 30 FILM COATED TABLETs in a BOTTLE

NDC: 63629-8891-2: 90 FILM COATED TABLETs in a BOTTLE

NDC: 63629-8891-3: 60 FILM COATED TABLETs in a BOTTLE

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Inform patients, families, or caregivers of the following before initiating therapy with ibuprofen and famotidine tablet and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2)].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop ibuprofen and famotidine tablet and seek immediate medical therapy [see Warnings and Precautions (5.4)].

Heart Failure and Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their health care provider if such symptoms occur [see Warnings and Precautions (5.6)].

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4), Warnings and Precautions (5.8)].

Serious Skin Reactions, including DRESS

Advise patients to stop taking ibuprofen and famotidine tablet immediately if they develop any type of rash or fever and contact their health care provider as soon as possible [see Warnings and Precautions (5.11, 5.12)].

Infertility

Advise females of reproductive potential who desire pregnancy that NSAIDs, including ibuprofen and famotidine tablet, may be associated with a reversible delay in ovulation [see Use in Specific Populations (8.3)].

Fetal Toxicity

Inform pregnant women to avoid use of ibuprofen and famotidine tablet and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus. If treatment with ibuprofen and famotidine tablet is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios [see Warnings and Precautions (5.13) and Use in Specific Populations (8.1)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of ibuprofen and famotidine tablet with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2, 5.17), Drug Interactions (7)]. Alert patients that NSAIDs may be present in the “over the counter” medications for treatment of colds, fever or insomnia.

Use of NSAIDs and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with ibuprofen and famotidine tablet until they talk to their health care provider [see Drug Interactions (7)].

Nephrotoxicity

Patients should be monitored for development of nephrotoxicity (e.g., azotemia, hypertension, and /or proteinuria). If these patients should be instructed to stop therapy and seek immediate medical therapy.

Creatinine Clearance

Ibuprofen and famotidine tablet is not recommended in patients with creatinine clearance <50 mL/min because of seizures, delirium, coma and other CNS effect.

Taking ibuprofen and famotidine tablet

Inform patients that ibuprofen and famotidine tablets should be swallowed whole, and should not be cut to supply a lower dose. Advise patient not to chew, divide, or crush tablets [see Dosage and Administration (2)].

Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054.

Revised: November, 2021

Medication Guide


IBUPROFEN and FAMOTIDINE

( EYE bue PROE fen and fa moe’ ti deen)

tablets, for oral use

What is the most important information I should know about ibuprofen and famotidine tablet?

Ibuprofen and famotidine tablet can cause serious side effects including:

  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

o with increasing doses of medicine containing NSAIDs o with longer use of medicine containing NSAIDs

Do not take ibuprofen and famotidine tablet right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking ibuprofen and famotidine tablet after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take ibuprofen and famotidine tablet after a recent heart attack.

  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
o anytime during use o without warning symptoms o that may cause death

The risk of getting an ulcer or bleeding increases with:

o past history of stomach ulcers, or stomach or intestinal bleeding with the use of NSAIDs o smokingo drinking alcoholo taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”o older ageo poor healtho increasing doses of NSAIDso advanced liver diseaseo longer use of NSAIDso bleeding problems

You should take ibuprofen and famotidine tablet exactly as prescribed, at the lowest dose possible and for the shortest time needed.

Ibuprofen and famotidine tablet contains a non-steroidal anti-inflammatory drug NSAID (ibuprofen). Do not use ibuprofen and famotidine tablet with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may contain an NSAID also.

Ibuprofen and famotidine tablet may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your healthcare provider.

Ibuprofen and famotidine tablet contains ibuprofen, an NSAID and famotidine, a histamine H2 -receptor blocker medicine.

What is ibuprofen and famotidine tablet?

Ibuprofen and famotidine tablet is a prescription medicine used to:

  • relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis.
  • decrease the risk of developing ulcers of the stomach and upper intestines (upper gastrointestinal ulcers) in people taking ibuprofen for rheumatoid arthritis and osteoarthritis.

It is not known if ibuprofen and famotidine tablet is safe and effective in children.

Do not take ibuprofen and famotidine tablet:

  • if you are allergic to ibuprofen, famotidine, any other histamine H2 -receptor blocker, or any of the ingredients in ibuprofen and famotidine tablet. See the end of this Medication Guide for a complete list of ingredients.
  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.

Before taking ibuprofen and famotidine tablet, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems.
  • have high blood pressure.
  • have heart problems.
  • have asthma.
  • have bleeding problems.
  • are pregnant or plan to become pregnant. Taking ibuprofen and famotidine tablet at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take ibuprofen and famotidine tablet when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take ibuprofen and famotidine tablet after about 30 weeks of pregnancy.
  • are breastfeeding or plan to breast feed. Ibuprofen and famotidine can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ibuprofen and famotidine tablet.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Ibuprofen and famotidine tablet and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

How should I take ibuprofen and famotidine tablet?

  • Take ibuprofen and famotidine tablet exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how many ibuprofen and famotidine tablet to take and when to take it.
  • Do not change your dose or stop ibuprofen and famotidine tablet without first talking to your healthcare provider.
  • Swallow ibuprofen and famotidine tablets whole with liquid. Do not split, chew, crush or dissolve the ibuprofen and famotidine tablet. Tell your healthcare provider if you cannot swallow the tablet whole. You may need a different medicine.
  • If you forget to take your dose of ibuprofen and famotidine tablet, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose.
  • You should not take an ibuprofen tablet and famotidine tablet together instead of taking ibuprofen and famotidine tablet, because they will not work in the same way.

What are the possible side effects of ibuprofen and famotidine tablet?

Ibuprofen and famotidine tablet can cause serious side effects, including:

See “What is the most important information I should know about ibuprofen and famotidine tablet?

  • heart attack
  • kidney problems including kidney failure
  • stroke
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • new or worse high blood pressure
  • life-threatening skin reactions
  • heart failure
  • low red blood cells (anemia)

Other side effects of ibuprofen and famotidine tablet include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

  • shortness of breath
  • slurred speech
  • chest pain
  • swelling of the face or throat
  • weakness in one part or side of your body

Stop taking ibuprofen and famotidine tablet and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • vomit blood
  • more tired or weaker than usual
  • there is blood in your bowel movement or it is black and sticky like tar
  • diarrhea
  • itching
  • unusual weight gain
  • your skin or eyes look yellow
  • skin rash or blisters with fever
  • indigestion or stomach pain
  • swelling of the arms, legs, hands, and feet
  • flu-like symptoms

If you take too much ibuprofen and famotidine tablet, call your poison control center at 1-800-222-1222. These are not all the possible side effects of ibuprofen and famotidine tablet. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

  • Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of ibuprofen and famotidine tablet

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ibuprofen and famotidine tablet for a condition for which it was not prescribed. Do not give ibuprofen and famotidine tablet to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

What are the ingredients in ibuprofen and famotidine tablet?

Active ingredients: ibuprofen and famotidine

Inactive ingredients: Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1/brilliant blue FCF aluminum, FD&C blue #2/indigo carmine aluminum lake, ferrosoferric oxide, hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc and titanium Dioxide.

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054.

For more information, you can call on Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901).

This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: November, 2021

PT 3450-02

Ibuprofen & Famotidine 800/26.6mg Tablet

Label
(click image for full-size original)
IBUPROFEN AND FAMOTIDINE ibuprofen and famotidine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8891(NDC:67877-626)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 26.6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SHELLAC
TALC
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color BLUE (light blue) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code IF826
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-8891-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63629-8891-2 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:63629-8891-3 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211890 08/04/2021
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-8891), RELABEL (63629-8891)

Revised: 10/2023 Bryant Ranch Prepack

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