Label: ARAMARK PAIN-FREE EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 81238-0560-2, 81238-0560-3 - 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 June 3, 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:
• Reye’s Syndrome: Children and teenagers should not
use this medicine for chicken pox or flu symptoms
before a doctor is consulted about Reye’s Syndrome,
a rare but serious illness reported to be associated
with aspirin.
• Allergy Alert - Do not use:
• if you are allergic to aspirin or any other salicylate
• if you have ever had an allergic reaction to any
other pain reliever/fever reducer
• Liver Warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen
(Prescription or nonprescription)
• Ask a doctor or pharmacist before using with
other drugs if you are not sure.
• 3 or more alcoholic drinks every day while
using this product.
• Stomach Bleeding Warning: This product contains
nonsteroidal anti-inflammatory drugs (NSAIDs),
which may cause 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 an NSAID (aspirin,
ibuprofen, naproxen, or others)
• take more or for a longer time than directed - DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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Package Labeling
aramark
100 TABLETS Part # 547R23
PER BOXPain-Free® Extra Strength
Maximum Strength
Pain RelieverTemporary relief of fever and
the pain of Sinusitis, headache,
toothache, muscular aches,
backache, menstrual discomfort,
minor arthritis pain and colds
and flu.Compare active ingredient to:
EXCEDRIN Migraine®
Registered Trademark of GlaxoSmithKline
MANUFACTURED FOR:
Aramark
Lenexa, KS 66219
(913) 269-9611aramarkuniform.com
Retain carton for complete product information
100 Tablet Box
250 Tablet Box
2-Tablet Packet
res
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INGREDIENTS AND APPEARANCE
ARAMARK PAIN-FREE EXTRA STRENGTH
acetaminophen, aspirin, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-0560 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code FR9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81238-0560-2 50 in 1 BOX 05/07/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:81238-0560-3 125 in 1 BOX 05/07/2021 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 05/07/2021 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(81238-0560) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 944090448 manufacture(81238-0560)