Aramark Ibuprofen

Manufacturer
Western First Aid Safety DBA Aramark | Ultra Seal Corporation
Effective date
2021-05-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:28

Label at a glance#

ProductAramark Ibuprofen
Active ingredientIBUPROFEN
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient (in each tablet)
​Ibuprofen 200 mg (NSAID)*

OTC - PURPOSE SECTION

Purpose
Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer

*nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE SECTION

Uses:
Temporarily Relieves minor aches and pains
due to:
• Headache, toothaches, menstrual cramps,
  the common cold,
• muscular aches, minor pain of arthritis
  Temporarily reduces fever

WARNINGS SECTION

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

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 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

OTC - DO NOT USE SECTION

Do not use:
• if you have ever had an allergic reaction to any
  other pain
• reliever/fever reducer
• right before or after heart surgery
• if you have ever had an allergic reaction to this
  product or any of its ingredients

OTC - ASK DOCTOR SECTION

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, or asthma
• you are taking a diuretic

OTC - ASK DOCTOR/PHARMACIST SECTION

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 the benefit of aspirin
• taking the blood thinning drug Warfarin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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
• 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 occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center
right away.

DOSAGE & ADMINISTRATION SECTION

Directions:
• do not take more than directed
• the smallest effective dose should be used
• 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
• do not exceed 6 tablets in 24 hours, unless
  directed by a doctor
• children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information:
read all warnings and directions before use. Keep
carton. Store at 20-25°C (68-77°F) avoid excessive
heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
colloidal silicon dioxide, corn starch, sodium starch
glycollate, hypromellose, lactose monohydrate,
povidone, pregelatinized corn starch, red iron oxide,
sodium starch glycolate, steric acid, talc, titanium
dioxide, triacetin, purified water

Product Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aramark

100 TABLETS PER BOX            Part # 552R23

Ibuprofen
Anti-Inflammatory Fever
Reducer

Compare active ingredient to:

ADVIL®
Registered Trademark of Pfizer Consumer Healthcare

Retain carton for complete product information

MANUFACTURED FOR:
Aramark
Lenexa, KS 66219
(913) 269-9611

aramarkuniform.com

100 Tablet Box

0103 100 Tab Box0103 100 Tab Box

250 Tablet Box

0103 250 Tab Box0103 250 Tab Box

2-Tablet Packet

0103 2-Tab Packet0103 2-Tab Packet

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN2
310965ibuprofen 200 MG Oral TabletSCD2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81238-0103-12023-01-30C16284748780-1f386c64a-129f-0266-e053-dadaa90a7c1aAramark Ibuprofen
81238-0103-22023-01-30C16284748780-1f386c64a-129f-0266-e053-dadaa90a7c1aAramark Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81238-0103-1Aramark Ibuprofen50 in 1 BOXTABLET502
81238-0103-1Aramark Ibuprofen2 in 1 PACKETTABLET22
81238-0103-2Aramark Ibuprofen125 in 1 BOXTABLET1252
81238-0103-2Aramark Ibuprofen2 in 1 PACKETTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81238-0103ARAMARK IBUPROFEN (IBUPROFEN) TABLET [WESTERN FIRST AID SAFETY DBA ARAMARK]2Legacy NDC, 4 package rows20210522_6481ca76-c9a6-4a15-84e4-4872e1b762ae.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81238-010381238-0103-1, 81238-0103-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b1a0cd90-c2ee-441f-a3d5-b0f100b681766481ca76-c9a6-4a15-84e4-4872e1b762ae2021-05-20WarningsExact identifier
spl id: b1a0cd90-c2ee-441f-a3d5-b0f100b68176
spl set id: 6481ca76-c9a6-4a15-84e4-4872e1b762ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.