OTC Medication Information: Ibuprofen

IBUPROFEN- ibuprofen capsule, liquid filled
TIME CAP LABORATORIES, INC.

DRUG FACTS

Active ingredient (in each capsule)
Solubilized Ibuprofen equal to
200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
* nonsteroidal anti-inflammatory drug

Purpose
Pain reliever/Fever reducer

Uses

• temporarily relieves minor aches and pains due to :

headache
toothache
backache
menstrual cramps
the common cold
muscular aches
minor pain of arthritis

• temporarily reduces fever

Warnings
Allergy alerts: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
  

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic
  

Ask a doctor or pharmacist before use if you are

• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug
  

When using this product

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:

feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better

• you have symptoms of heart problems or stroke:

chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

do not take more than directed​

the smallest effective dose should be use

adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist

• if pain or fever does not respond to 1 capsule, 2 capsules may be used
• do not exceed 6 capsules in 24 hours, unless directed by a doctor

children under 12 years: ask a doctor

OTHER INFORMATION

Other information

• each capsule contains: potassium 20 mg
• read all warnings and directions before use
• store at 20-25°C(68-77 ^° F)
• avoid excessive heat above 40°C(104 ^° F)

Inactive ingredients Ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Questions or comments? call 1-877-290-4008

IBUPROFEN ibuprofen capsules 200 mg capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-133 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg

Inactive Ingredients Ingredient Name Strength WATER SHELLAC FD&C GREEN NO. 3 AMMONIA GELATIN FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL, UNSPECIFIED MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE GLYCOL POTASSIUM HYDROXIDE SORBITAN MONOOLEATE SORBITOL

Product Characteristics Color green Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 133 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49483-133-31 300 CAPSULE, LIQUID FILLED in 1 BOTTLE None 2 NDC:49483-133-23 1 BOTTLE in 1 CARTON contains a BOTTLE 2 20 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (49483-133-23) 3 NDC:49483-133-80 80 CAPSULE, LIQUID FILLED in 1 BOTTLE None 4 NDC:49483-133-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE None 5 NDC:49483-133-20 200 CAPSULE, LIQUID FILLED in 1 BOTTLE None 6 NDC:49483-133-37 160 CAPSULE, LIQUID FILLED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 07/27/2021

Labeler — TIME CAP LABORATORIES, INC. (037052099)

Registrant — TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Operations
MARKSANS PHARMA LIMITED		925822975	manufacture (49483-133)

Revised: 09/2023 TIME CAP LABORATORIES, INC.