LIL DRUG STORE IBUPROFEN- ibuprofen tablet

Lil Drug Store Ibuprofen by

Drug Labeling and Warnings

Lil Drug Store Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID1)

1 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

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
- 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 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 older:
- take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Other information

store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Vial Label

QUALITY GUARANTEED

Compare to the Active
Ingredient in Advil®**

Ibuprofen

Pain Reliever/Fever Reducer
(NSAID), 200 mg

12
Tablets

Lil'
Drug Store®

OPEN HERE FOR DRUG FACTS INFORMATION

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Vial Label

INGREDIENTS AND APPEARANCE

LIL DRUG STORE IBUPROFEN
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9739
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
Carnauba Wax (UNII: R12CBM0EIZ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Starch, Corn (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Ferric Oxide Red (UNII: 1K09F3G675)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
Magnesium Stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
Polydextrose (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;352
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 66715-9739-3	3 in 1 CARTON	01/27/2011	05/11/2021
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9739-8	10 in 1 CARTON	01/27/2011	07/17/2018
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 66715-9739-9	30 in 1 CARTON	01/27/2011	07/17/2018
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 66715-9739-4	12 in 1 VIAL; Type 0: Not a Combination Product	05/23/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075010	01/27/2011

Labeler - Lil' Drug Store Products, Inc. (093103646)