IBUPROFEN MINI- ibuprofen mini 200 mg capsule, liquid filled

Drug Details [pdf]

DRUG FACTS
ACTIVE INGREDIENT

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

Purpose

Pain reliever/Fever reducer
INDICATIONS & USAGE
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
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
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 DOCTOR
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 DOCTOR/PHARMACIST
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
When using this product
- take with food or milk if stomach upset occurs
STOP USE
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
PREGNANCY OR BREAST FEEDING

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
DOSAGE & ADMINISTRATION
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 SAFETY INFORMATION
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 INGREDIENT

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, sorbital sorbitan
QUESTIONS

Questions or comments? call 1-800-910-6874
PRINCIPAL DISPLAY PANEL

IBUPROFEN MINI
ibuprofen mini 200 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-683
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
FERROUS OXIDE (UNII: G7036X8B5H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AMMONIA (UNII: 5138Q19F1X)
SORBITOL (UNII: 506T60A25R)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	6mm
Flavor		Imprint Code	62
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 11673-683-32	300 in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2021
2	NDC: 11673-683-80	1 in 1 CARTON	12/17/2021
2		80 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 11673-683-66	1 in 1 CARTON	12/17/2021
3		160 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079205	12/17/2021

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
MARKSANS PHARMA LIMITED		925822975	manufacture(11673-683)

IBUPROFEN MINI- ibuprofen mini 200 mg capsule, liquid filled

Ibuprofen Mini by

Drug Labeling and Warnings

Drug Details [pdf]