ARAMARK BACK RELIEF- magnesium salicylate tablet

Aramark Back Relief by

Drug Labeling and Warnings

Aramark Back Relief by is a Otc medication manufactured, distributed, or labeled by Western First Aid Safety DBA Aramark, ULTRA SEAL CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet)
Acetaminophen 250 mg
Cafeine 50mg
*Nonsteroidal anti-inflammatory drug
Magnesium Salicylate (NSAID) 290 mg

PURPOSE

Purpose
Acetaminophen ....Pain Reliever/Fever Reducer
Cafeine .........................................Adjuvent
*Nonsteroidal anti-inflammatory drug
Magnesium Salicylate (NSAID) ......Pain Reliever

INDICATIONS & USAGE

Uses:
Temporarily Relieves minor aches and pains
associated with: back pain muscular aches

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 surgery

Ask 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 older

Ask 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 drug

When 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

If pregnant or breast-feeding baby, ask a health
professional before use. IT IS ESPECIALLY
IMPORTANT NOT TO USE ASPIRIN DURING THE
LAST 3 MONTHS OF PREGNANCY UNLESS
SPECIFICALLY 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

KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a
Poison Control Center right away. Prompt medical
attention is critical for adults as well as children
even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

• Directions: Adults andchildren 12 yearsof age and older:

  2 tablets as; needed for pain; every 4 hours. Do; not exceed 8 tablets; in 24 hours or as; directed by a doctor.

• Children under12 years: Do not give to; children under 12 years; of age

OTHER SAFETY INFORMATION

Other Information:
read all product information before using
store at room temperature 59°-86°F (15°-30°C)
avoid excessive heat and humidity
tamper-evident sealed packets
do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive Ingredients:
hypromellose, maltodextrin, microcrystalline
cellulose, polyethylene glycol, povidone,
starch 1551, stearic acid, titanium dioxide

Product Labeling

aramark

100 Tablets                        Part # 07333

Per Box

Back Relief

Pain Reliever/Fever Reducer

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
(866) 362-2691

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

2-tablet Packet

INGREDIENTS AND APPEARANCE

ARAMARK BACK RELIEF 
magnesium salicylate tablet

Product 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)