BACKPRIN- acetaminophen, caffeine, salicylamide tablet 
HART Health

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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BACKPRIN

Active Ingredients (in each tablet):

Acetaminophen 250 mg

Caffeine 50 mg

Magnesium Salicylate (NSAID*) 290 mg (*nonsteroidal anti-inflammatory drug)

Purpose:

Pain Reliever/Fever Reducer

Pain Reliever Aid

Pain Reliever/Fever Reducer

Uses:

Temporarily relieves minor back pain

Warnings:

Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with salicylates.

Allergy alert: Acetaminophen and Magnesium Salicylate may cause severe allergic reaction which may include hives, skin reddening, blisters, rash, facial swelling, asthma (wheezing), or shock.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is highter if you:

Do not use:

Ask a doctor before use if

Ask a doctor or pharmacist before use if you

Stop use and ask a doctor if:

   These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates 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.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symtoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions:

Do not take more than directed

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

Inactive Ingredients:

Hypromellose, Maltodextrin, Microcystalline Cellulose, Povidone, Polyethylene Glycol, Starch, Stearic Acid, Titanium Dioxide

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BACKPRIN 
acetaminophen, caffeine, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0116
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE290 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0116-450 in 1 BOX, UNIT-DOSE07/14/2000
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0116-2125 in 1 BOX, UNIT-DOSE07/14/2000
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/14/2000
Labeler - HART Health (069560969)

Revised: 6/2020
Document Id: 5963362c-d180-49bd-be56-f2776ac7e746
Set id: a9301898-2c72-4ec0-bba1-1a2eb1962a38
Version: 2
Effective Time: 20200605
 
HART Health