Celecoxib: Package Insert and Label Information (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Celecoxib 50 mg capsules are white to off-white powder filled in size “4” hard gelatin capsule with red opaque cap imprinted “C85” and white opaque body imprinted “50”, supplied as:

NDC Number Size
71209-054-03 bottle of 60
71209-054-11 bottle of 1000

Celecoxib 100 mg capsules are white to off-white powder filled in size “3” hard gelatin capsule with blue opaque cap imprinted “C86” and white opaque body imprinted “l00”, supplied as:

NDC Number Size
71209-055-03 bottle of 60
71209-055-05 bottle of 100
71209-055-10 bottle of 500
71209-055-11 bottle of 1000

Celecoxib 200 mg capsules are white to off-white powder filled in size “2” hard gelatin capsule with gold opaque cap imprinted “C87” and white opaque body imprinted “200”, supplied as:

NDC Number Size
71209-056-03 bottle of 60
71209-056-05 bottle of 100
71209-056-10 bottle of 500
71209-056-11 bottle of 1000

Celecoxib 400 mg capsules are white to off-white powder filled in size “00” hard gelatin capsule with green opaque cap imprinted “C88” and white opaque body imprinted “400”, supplied as:

NDC Number Size
71209-057-03 bottle of 60
71209-057-20 bottle of 600

Storage: Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]

17 PATIENT COUNSELING INFORMATION


Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with celecoxib 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, diarrhea jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop celecoxib and seek immediate medical therapy [see Warnings and Precautions (5.3), Use in Specific Populations (8.6)].
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 healthcare provider if such symptoms occur [see Warnings and Precautions (5.5) ].
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) and Warnings and Precautions (5.7)].
Serious Skin Reactions including DRESS
Advise patients to stop celecoxib immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9, 5.10)].
Female Fertility
Advise females of reproductive potential who desire pregnancy that NSAIDs, including celecoxib, 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 celecoxib and other NSAIDs starting at 30 weeks of gestation because of the risk of the premature closing of the fetal ductus arteriosus If treatment with celecoxib is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1)].
Avoid Concomitant Use of NSAIDs
Inform patients that the concomitant use of celecoxib 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) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in “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 celecoxib capsules until they talk to their healthcare provider [see Drug Interactions (7)].
Manufactured by:
Cadila Pharmaceuticals Limited
1389 Trasad Road,
Dholka – 387810,
District — Ahmedabad, Gujarat, INDIA
Revised: September/2021

Medication Guide for Non-Steroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs 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:

    • with increasing doses of NSAIDs

    • with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
Avoid taking NSAIDs 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 NSAIDs 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:
    • anytime during use
    • without warning symptoms
    • 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 use of NSAIDs
o taking medicines called “corticosteroids”,“antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs”
o increasing doses of NSAIDs o older age
o longer use of NSAIDs o poor health
o smoking o advanced liver disease
o drinking alcohol o bleeding problems

NSAIDs should only be used:
•exactly as prescribed
•at the lowest dose possible for your treatment
•for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take NSAIDs?
Do not take NSAIDs:
•if you have an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
•right before or after heart bypass surgery.


Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:


  • have liver or kidney problems

  • have high blood pressure

  • have asthma
  • are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days 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 NSAIDs after about 30 weeks of pregnancy
  • are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs 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.
What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?


  • new or worse high blood pressure

  • heart failure

  • liver problems including liver failure

  • kidney problems including kidney failure

  • low red blood cells (anemia)

  • life-threatening skin reactions

  • life-threatening allergic reactions

  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

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

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

Stop taking your NSAID and call your healthcare provider right away if you have any of the following symptoms:

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

If you take too much of your NSAID, call your healthcare provider or get medical help right away.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.
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 NSAIDs


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Cadila Pharmaceuticals Limited
1389, Dholka, District — Ahmedabad,
Gujarat State, INDIA.
Revised: September/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL — 50 mg Bottle Label



PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-054-03
Celecoxib capsules
50 mg
60 CapsulesRx only

container-label-50mg-60packs
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Bottle Label
PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-055-03
Celecoxib capsules
100 mg
60 CapsulesRx only

container-label-100mg-60packs
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg Bottle Label
PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-056-03
Celecoxib capsules
200 mg
60 CapsulesRx only

container-label-200mg-60packs
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 400 mg Bottle Label
PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT.
NDC 71209-057-03
Celecoxib capsules
400 mg
60 Capsules
Rx only

container-label-400mg-60packs
(click image for full-size original)

CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-054
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, RED Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code C85;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-054-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-054-11 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/09/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-055
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, BLUE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code C86;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-055-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-055-11 1000 CAPSULE in 1 BOTTLE None
3 NDC:71209-055-05 100 CAPSULE in 1 BOTTLE None
4 NDC:71209-055-10 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/08/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, YELLOW (GOLD) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code C87;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-056-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-056-11 1000 CAPSULE in 1 BOTTLE None
3 NDC:71209-056-05 100 CAPSULE in 1 BOTTLE None
4 NDC:71209-056-10 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/15/2015
CELECOXIB celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELECOXIB (CELECOXIB) CELECOXIB 400 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSPOVIDONE
SODIUM LAURYL SULFATE
POVIDONE K30
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
AMMONIA
WATER
ALCOHOL
Product Characteristics
Color WHITE, GREEN Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code C88;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-057-03 60 CAPSULE in 1 BOTTLE None
2 NDC:71209-057-20 600 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208701 12/15/2015
Labeler — Cadila Pharmaceuticals Limited (862257719)
Establishment
Name Address ID/FEI Operations
Cadila Pharmaceuticals Limited 918451696 ANALYSIS (71209-054), ANALYSIS (71209-055), ANALYSIS (71209-056), ANALYSIS (71209-057), LABEL (71209-054), LABEL (71209-055), LABEL (71209-056), LABEL (71209-057), MANUFACTURE (71209-054), MANUFACTURE (71209-055), MANUFACTURE (71209-056), MANUFACTURE (71209-057), PACK (71209-054), PACK (71209-055), PACK (71209-056), PACK (71209-057)

Revised: 09/2021 Cadila Pharmaceuticals Limited

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