![BACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]](https://medic.hrt.org//dailymed/images/b0a91a7f-bef4-47c8-9813-66279997b173/Back Pain.jpg)
![BACK RELIEF (ACETAMINOPHEN, MAGNESIUM SALICYLATE) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]](https://medic.hrt.org//dailymed/images/b0a91a7f-bef4-47c8-9813-66279997b173/NORTH Back Relief.jpg)
| NDC | 0498-2101-01, 0498-2101-10, 0498-2102-01, 0498-2102-10 |
| Set ID | b0a91a7f-bef4-47c8-9813-66279997b173 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Honeywell Safety Products USA, Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active Ingredients (in each tablet)
- Purpose
- Uses
-
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: magnesium salicylate 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 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 4,00 mg in 24 hours, which is the maximum daily amount,
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while taking 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 any other drugs containing precription or nonprescription NSAIDs (aspirin,ibuprofen,naproxen or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for longer time than directed
Do not use
- if you ever had an allergic reaction to acetaminophen, magnesium salicylate or any other pain reliever/ fever reducer
- with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if
- you have liver disease
- 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 are taking a diuretic
- you have asthma
Stop using 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
- pain gets worse or lasts more than 10 days'
- fever gets worse or lasts for more than 3 days
- redness or swelling is present in painful area
- ringing in the ears or a loss of hearing occurs
- any new symptoms appear.
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments
- PRINCIPAL DISPLAY PANEL
- Back Relief label
-
INGREDIENTS AND APPEARANCE
BACK RELIEF
acetaminophen, magnesium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 200 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color pink (Pink) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-2101-10 50 in 1 CARTON 05/14/2013 12/20/2017 1 NDC:0498-2101-01 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 05/14/2013 12/20/2017 BACK RELIEF
acetaminophen, magnesium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 200 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) D&C RED NO. 28 (UNII: 767IP0Y5NH) Product Characteristics Color pink (Pink) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-2102-10 100 in 1 CARTON 12/20/2017 1 NDC:0498-2102-01 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 12/20/2017 Labeler - Honeywell Safety Products USA, Inc (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc 079287321 manufacture(0498-2101) , repack(0498-2102)
