IBUPROFEN MINIS- ibuprofen capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Family Dollar (FAMILY WELLNESS)
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps - headache - muscular aches - minor pain of arthritis - toothache - backache - the common cold - menstrual cramps - temporarily reduces fever
Authorization status:
Abbreviated New Drug Application
Authorization number:
55319-843-20

IBUPROFEN MINIS- ibuprofen capsule, liquid filled

Family Dollar (FAMILY WELLNESS)

----------

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

Purpos e

Pain reliever/fever reducer

Us es

temporarily relieves minor aches and pains due to:

headache

muscular aches

minor pain of arthritis

toothache

backache

the common cold

menstrual cramps

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

the 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

have bloody or black stools

vomit blood

have stomach pain that does not get better

you have symptoms of heart problems or stroke:

chest pain

slurred speech

trouble breathing

leg swelling

weaknessin one part or side of body

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 during the last 3

months of 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. Keep carton.

store at 20° to 25°C (68° to 77°F)

avoid excessive heat above 40°C (104°F).

swallow whole, do not crush, chew, or dissolve

Inactive ingredients

FD&C green #3, gelatin, medium-chain triglycerides, polyethylene glycol, potassium hydroxide,

purified water, sorbitan, sorbitol solution, white ink

Questions or comments?

Call 1-877-753-3925 Monday-Friday 7AM-6PM PST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN ADVIL® LIQUI-GELS® MINIS†

Ibuprofen

Capsules 200 mg

Pain Reliever/Fever Reducer (NSAID)

Minis

Softgels†

(†Liquid-Filled Capsules)

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil®

Liqui-Gels® minis.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN

OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Product Label

FAMILY WELLNESS Ibuprofen 200 mg Mini Softg els

IBUPROFEN MINIS

ibuprofen capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55319 -8 43

Route of Administration

ORAL

Family Dollar (FAMILY WELLNESS)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

GELATIN (UNII: 2G8 6 QN327L)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

Product Characteristics

Color

GREEN (Clear)

S core

no sco re

S hap e

CAPSULE

S iz e

13mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:55319 -8 43-

1 in 1 BOX

0 3/31/20 19

1

20 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 6 56 8

0 3/31/20 19

Labeler -

Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 11/2019

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