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 alert: 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 used
  • 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

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

Inactive ingredients ammonium hydroxide, FD&C green no.3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Questions or comments?

Call 1-877-290-4008

700T-Ibuprofen-240ct-label
(click image for full-size original)

IBUPROFEN
ibuprofen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-700
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
AMMONIA
SORBITAN MONOOLEATE
MEDIUM-CHAIN TRIGLYCERIDES
FD&C GREEN NO. 3
SHELLAC
POTASSIUM HYDROXIDE
GELATIN
PROPYLENE GLYCOL
WATER
FERROUS OXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
SORBITOL
Product Characteristics
Color green Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code 62
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-700-39 240 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079205 10/23/2023
Labeler — TIME CAP LABORATORIES, INC. (037052099)
Registrant — TIME CAP LABORATORIES, INC. (037052099)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 manufacture (49483-700)

Revised: 10/2023 TIME CAP LABORATORIES, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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