![PAIN RELIEF BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET, FILM COATED [RITE AID CORPORATION]](https://medic.hrt.org//dailymed/images/a71392c8-3f5b-4d00-baba-a4055ed68bc1/rite-aid-44-413-1.jpg)
| NDC | 11822-4130-2, 11822-4130-5 |
| Set ID | a71392c8-3f5b-4d00-baba-a4055ed68bc1 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Rite Aid Corporation |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredients (in each caplet)
- Purpose
- 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: Aspirin may cause a severe allergic reaction, which may include:
- hives
- facial swelling
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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
- have had stomach ulcers or bleeding problems
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:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs. Seek 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
- Other information
- Inactive ingredients
- Questions or Comments?
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Principal display panel
Rite
Aid®
PHARMACY**Compare to the active ingredients in Bayer® Back & Body
EXTRA STRENGTH
pain relief
back & bodyaspirin (NSAID) and caffeine
pain reliever/pain reliever aid100 CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Back & Body.
50844 ORG011341312
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.
Rite Aid 44-413
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INGREDIENTS AND APPEARANCE
PAIN RELIEF BACK AND BODY EXTRA STRENGTH
aspirin, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-4130 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color WHITE Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;413 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-4130-5 1 in 1 CARTON 04/12/2004 11/15/2020 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:11822-4130-2 1 in 1 CARTON 04/12/2004 10/01/2022 2 100 in 1 BOTTLE; 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 04/12/2004 10/01/2022 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(11822-4130) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(11822-4130) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(11822-4130) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(11822-4130)