Label: ARAMARK IBUPROFEN- ibuprofen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 81238-0103-1, 81238-0103-2 - Packager: Western First Aid Safety DBA Aramark
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 20, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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, blistersStomach 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 - DO NOT USE
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ASK DOCTOR
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 - ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
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 - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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
- INACTIVE INGREDIENT
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Product Package
aramark
100 TABLETS PER BOX Part # 552R23
Ibuprofen
Anti-Inflammatory Fever
ReducerCompare active ingredient to:
ADVIL®
Registered Trademark of Pfizer Consumer HealthcareRetain carton for complete product information
MANUFACTURED FOR:
Aramark
Lenexa, KS 66219
(913) 269-9611aramarkuniform.com
100 Tablet Box
250 Tablet Box
2-Tablet Packet
res
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INGREDIENTS AND APPEARANCE
ARAMARK IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-0103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POVIDONE (UNII: FZ989GH94E) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score no score Shape ROUND Size 15mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81238-0103-1 50 in 1 BOX 05/14/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:81238-0103-2 125 in 1 BOX 05/14/2021 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/14/2021 Labeler - Western First Aid Safety DBA Aramark (043861524) Registrant - Western First Aid Safety DBA Aramark (043861524) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(81238-0103) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 944090448 manufacture(81238-0103)