BACKPRIN- acetaminophen, caffeine, salicylamide tablet

Backprin by

Drug Labeling and Warnings

Backprin by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet):

Acetaminophen 250 mg

Caffeine 50 mg

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

PURPOSE

Purpose:

Pain Reliever/Fever Reducer

Pain Reliever Aid

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

Uses:

Temporarily relieves minor back pain

WARNINGS

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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

• take more or for a longer time than directed
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• have 3 or more alcoholic drinks every day while using this product
• take other drugs containing prescription or non-prescription NSAID (aspirin, ibuprofen, naproxen, others)

DO NOT USE

Do not use:

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or non-prescription)

ASK DOCTOR

Ask a doctor before use if

• you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
• stomach bleeding warning applies to you
• you are taking a diuretic
• you have a history of stomach problems, such as heartburn

Ask a doctor or pharmacist before use if you

• take a blood thinning (anticoagulant) or steroid drug
• take any drug for diabetes, gout or arthritis
• do not know if other drugs you are taking contain acetaminophen
• take any other drug containing an NSAID

STOP USE

Stop use and ask a doctor if:

• an allergic reaction occurs, seek medical help right away
• fever worsens or lasts for more than 3 days
• redness or swelling is present
• new symptoms occur
• pain worsens or lasts for more than 10 days
• ringing in the ears or a loss of hearing occurs
• you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloods or black stools, or stomach pain that does not get better

   These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

Keep out of reach of children.

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

Directions:

Do not take more than directed

Adults and children 12 years of age and over:

• take 2 tablets with water every 4 hours while symptoms persist.
• do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACKPRIN 
acetaminophen, caffeine, salicylamide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	50 mg
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MAGNESIUM SALICYLATE	290 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0116-4	50 in 1 BOX, UNIT-DOSE	07/14/2000
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0116-2	125 in 1 BOX, UNIT-DOSE	07/14/2000
2		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	07/14/2000

Labeler - HART Health (069560969)