Label: ARAMARK BACK RELIEF- magnesium salicylate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 81238-1118-1 - 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 24, 2021
If you are a consumer or patient please visit this version.
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- 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: Saticylates (NSAIDs) may cause a severe
allergic reaction which may include: • hives • shock
• facial swelling • asthma (wheezing)If a skin or allergic reaction occurs, stop use
and seek medical help right away.
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:
• with any other pain reliever/fever reducer
• for pain for more than 10 days or for fever for
more than 3 days unless directed by a doctor
• with any other product containing
acetaminophen
• right before or after heart surgeryAsk a doctor before using if you have:
• upset stomach or stomach pain • ulcers
• bleeding problems • high blood pressure • heart or
kidney disease • taken a diuretic • reached age 60
or olderAsk a doctor or pharmacist before use if you are:
• taking any other drug containing an NSAID
(prescription or nonprescription)
• taking a blood thinning (anticoagulant) or
steroid drugWhen using this product do not exceed the
recommended dose.Caffeine warning: The recommended dose of this
product contains about as much caffeine as a cup of coffee.
Limit the use of careline-containing medications, foods, or
beverages while taking this product because too much careline
may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heartbeat.Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood, or have bloody or
black stools.
• These are signs of stomach bleeding. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Product Labeling
-
INGREDIENTS AND APPEARANCE
ARAMARK BACK RELIEF
magnesium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-1118 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 50 mg MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 290 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81238-1118-1 50 in 1 BOX 06/14/2021 1 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 06/14/2021 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(81238-1118) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 944090448 manufacture(81238-1118)