![BACK AND BODY EXTRA STRENGTH (ASPIRIN, CAFFEINE) TABLET, FILM COATED [CARDINAL HEALTH]](https://medic.hrt.org//dailymed/images/519eb216-9fa6-4d60-a2a4-3310bdb5b4ab/leader-44-413-1.jpg)
| NDC | 70000-0127-1, 70000-0127-2 |
| Set ID | 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Cardinal Health 110, LLC. DBA Leader |
| 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
- are age 60 or older
- take more or for a longer time than directed
- 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
- have had stomach ulcers or bleeding problems
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
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
- an allergic reaction occurs. Seek medical help right away.
- 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
- ringing in the ears or a 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
- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
LEADER™
NDC 70000-0127-2
Extra Strength
Back & Body
Aspirin (NSAID), 500 mg | Caffeine, 32.5 mg
Pain Reliever | Pain Reliever AidRelieves Backaches
and Muscle Aches & PainsCOMPARE TO
BAYER® BACK & BODY
active ingredients†100% Money Back Guarantee
100 CAPLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING†This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer® Back & Body.
50844 REV0818A41312CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979100%
Money Back Guarantee
Return to place of purchase if not satisfied.© 2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE,
LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the
property of their respective owners.
Leader 44-413
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INGREDIENTS AND APPEARANCE
BACK AND BODY EXTRA STRENGTH
aspirin, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0127 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) MICROCRYSTALLINE CELLULOSE (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:70000-0127-1 1 in 1 CARTON 04/12/2004 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:70000-0127-2 1 in 1 CARTON 04/12/2004 2 100 in 1 BOTTLE, PLASTIC; 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 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(70000-0127) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70000-0127) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70000-0127) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(70000-0127)