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
Dye-free Ibuprofen Capsule, Liquid Filled
FDA Label NDC 11822-1879
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Dye-free Ibuprofen (NDC 11822-1879). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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
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
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be 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 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
- 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° to 25°C (68° to 77°F)
- avoid excessive heat above 40°C (104°F). Protect from light.
Inactive Ingredients
gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol
Questions Or Comments?
call toll free 1-888-235-2466
Other
†All trademarks are property of their respective owners. This product is not affiliated with the owners of Motrin ®IB Liquid Gels.
DISTRIBUTED BY: RITE AID,
30 HUNTER LANE, CAMP HILL,
PA 17011 www.riteaid.com
SATISFACTION GUARANTEE:
If you're not satisfied, we'll
happily refund your money.
REV# 03/21
L0000416
120'S Bottle Label
NDC 118/22-1879-1
Compare to the active ingredient in Motrin ® IB Liquid-Gels †
DYE FREE
IBUPROFEN
IBUPROFEN CAPSULES 200 mg
PAIN RELIEVER /
FEVER REDUCER
(NSAID)
ACTUAL SIZE
DO NOT USE IF TAMPER-EVIDENT
SEAL UNDER BOTTLE CAP
IMPRINTED WITH “ SEALED for
YOUR PROTECTION” IS BROKEN
OR MISSING.
120
LIQUID GELS**
(**LIQUID-FILLED CAPSULES)
Front
Front (Front)
Back
Back (Back)
* Please review the disclaimer below.
