FDA Label for Aramark Back Relief
View Indications, Usage & Precautions
Aramark Back Relief Product Label
The following document was submitted to the FDA by the labeler of this product Western First Aid Safety Dba Aramark. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient (in each tablet)
Acetaminophen 250 mg
Cafeine 50mg
*Nonsteroidal anti-inflammatory drug
Magnesium Salicylate (NSAID) 290 mg
Otc - 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.
Otc - 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.
Otc - 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: | 2 tablets as |
| • Children under 12 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
* Please review the disclaimer below.