IBUPROFEN- ibuprofen tablet, film coated
DOLGENCORP, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rite Aid 44-329

Active ingredient (in each brown tablet)

Ibuprofen USP,
200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- headache
- the common cold
- toothache
- muscular aches
- backache
- minor pain of arthritis
- temporarily reduces fever
menstrual cramps

Warnings

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

hives
facial swelling
asthma (wheezing)
skin reddening
shock
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:

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

Do not use

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

Ask a doctor before use if

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

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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
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.

Directions

do not take more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directed by a doctor (see Warnings)
adults and children 12 years and over: 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
children under 12 years: ask a doctor

do not exceed 6 tablets in 24 hours, unless directed by a doctor

Other information

store between 20°-25°C (68°-77°F)
avoid excessive heat 40°C (104°F)
see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

DG™
health

Compare to active ingredient in Advil® Tablets†

Ibuprofen
Tablets 200 mg
Pain Reliever/Fever Reducer
(NSAID)

SEE NEW WARNINGS INFORMATION

50 Coated Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 ORG091029115

DISTRIBUTED BY DOLGENCORP, LLC
100 MISSIONS RIDGE
GOODLETTSVILLE, TN 37072

100% QUALITY GUARANTEED
(888) 309-9030

Product Packaging

IBUPROFEN
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-291
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;291
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55910-291-12	1 in 1 CARTON	05/24/1988	09/13/2016
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:55910-291-15	1 in 1 CARTON	05/24/1988	09/13/2016
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:55910-291-13	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/24/1988	09/13/2016
4	NDC:55910-291-14	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/24/1988	09/13/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	05/24/1988	09/13/2016

Labeler - DOLGENCORP, LLC (068331990)

Revised: 2/2017

Document Id: e676fa85-fee8-438d-abf7-f8cce2fc1bdf

Set id: 1a82471a-09d6-4f26-b27b-5dc5fd32d151

Version: 5

Effective Time: 20170220

DOLGENCORP, LLC