OTIS CLAPP BACK QUELL- magnesium salicylate, acetaminophen tablet, film coated
Otis Clapp Back Quell by
Drug Labeling and Warnings
Otis Clapp Back Quell by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Prestige Packaging. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each tablet)
- Purposes
- Uses
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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 ■ facial swelling ■ asthma (wheezing) ■ shock
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
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 4,0000 mg of acetaminophen in 24 hours
- 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
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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel - OC Back Quell Label
Otis Clapp
Quality and Integrity Since 1840
BACK QUELL ™
Pain Reliever
Back Pain Relief
Muscles and Sprains
See Warnings and Directions on Side Panel
Acetaminophen 200 mg,
Magnesium Salicylate (NSAID) 200 mg
Tear Out Along Perforation To Dispense
PROFESSIONAL HEALTHCARE
300 Tablets (150 PACKETS OF 2)
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INGREDIENTS AND APPEARANCE
OTIS CLAPP BACK QUELL
magnesium salicylate, acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 47682-587 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 200 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 28 (UNII: 767IP0Y5NH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color pink (pink) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 47682-587-03 150 in 1 BOX 12/30/2008 1 NDC: 47682-587-99 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 12/30/2008 Labeler - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 170837962 relabel(47682-587) , repack(47682-587)
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