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Otis Clapp Back Quell

Unifirst First Aid Corporation

Otis Clapp Back Quell

FULL PRESCRIBING INFORMATION: CONTENTS*

Active ingredients (in each tablet)
Purposes
Otis Clapp Back Quell Uses
Warnings
Directions
Otis Clapp Back Quell Other information
Inactive ingredients
Questions or comments? 1-800-634-7680
Principal Display Panel - 202R OC Back Quell Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 200 mg

Magnesium Salicylate U.S.P. (NSAID*) 200 mg

magnesium (total) 13 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with:

back pain
muscular aches

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

hives
skin reddening
facial swelling
rash
asthma (wheezing)
shock
blisters

If an 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, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Stomach 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 or nonprescription 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

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
for pain for more than 10 days unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you ever have had an allergic reaction to any other pain relievers/ fever reducers
right before or after heart surgery
if you are taking prescription drugs for gout, diabetes, or arthritis

Ask a doctor before use if

stomach bleeding warning applies to you
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have a history of stomach problems such as heartburn

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
under a doctor's care for any serious condition
taking any other drug

When using this product

take with food or milk if stomach upset occurs

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
symptoms do not improve
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
ringing in the ears or loss of hearing occurs
redness or swelling is present in the painful area
any new symptoms appears

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely 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. 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 for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets as needed for pain every 6 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Other information

each dose contains 26mg of Magnesium
tamper evident, do not use if packet is torn, cut or opened.
store at controlled room temperature 15º-30ºC (59º to 86ºF)
avoid excessive heat and humidity

Inactive ingredients

D&C Red #28, microcrystalline cellulose, povidone, starch, stearic acid

Questions or comments? 1-800-634-7680

Principal Display Panel - 202R OC Back Quell Label

Otis Clapp

Quality and Integrity Since 1840

BACK QUELL ™

Pain Reliever

New Formula

Back Pain Relief

Muscles and Sprains

See Warnings and Directions on Side Panel

See new warnings information

Acetaminophen 200 mg,

Magnesium Salicylate (NSAID) 200 mg

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 Tablets (150 PACKETS OF 2)