EXTRA STRENGTH BACK AND BODY- aspirin and caffeine capsule
GREENBRIER INTERNATIONAL, INC.
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.
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Assured 44-413
Active ingredient (in each caplet)
Aspirin 500 mg (NSAID)*
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug
Uses
for the temporary relief of:
- backache pain
- muscle aches and pains
- minor aches and pains of arthritis
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: Aspirin may cause a severe allergic reaction, which may include:
- hives
- facial swelling
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains and 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
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- have bloody for black stools
- vomit blood
- feel faint
- have stomach pain that does not get better
- an allergic reaction occurs. Seeks medical help right away.
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- These could be signs of a serious condition.
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
- children under 12 years: do not use unless directed by a doctor
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date or lot number
Inactive ingredients
corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate
Principal Display Panel
ASSURED®
COMPARE TO ACTIVE INGREDIENTS IN BAYER® Back & Body†
EXTRA STRENGTH
BACK & BODY
Aspirin (NSAID) & Caffeine
PAIN RELIEVER/PAIN RELIEVER AID
Fast Pain Relief at the site of Pain
24 COATED CAPLETS
†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Back & Body.
50844 REV0113A41308
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING
Assured 44-413
| EXTRA STRENGTH BACK AND BODY
aspirin, caffeine capsule |
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| Labeler - GREENBRIER INTERNATIONAL, INC. (610322518) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(33992-0413) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(33992-0413) | |