Label: BACKPRIN- acetaminophen, caffeine, salicylamide tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50332-0116-2, 50332-0116-4 - Packager: HART Health
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated June 5, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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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
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BACKPRIN
acetaminophen, caffeine, salicylamide tabletProduct 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)