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Active Ingredient
Acetaminophen 110 mg .....................................................................................pain reliever/fever reducer
Aspirin 162 mg .....................................................................................................pain reliever/fever reducer
Caffeine 32.4 mg...............................................................................................................................adjuvant
Salicylamide 152 mg............................................................................................pain reliever/fever reducer
- Uses:
- Warnings: Reye’s syndrome:
- Liver Warning:
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Stomach Bleeding Warning:
This product contains a non-steroidal anti-inflammatory drug (NSAIDs), which may cause stomach bleeding. The chance is higher if you ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ have 3 or more alcoholic drinks every day while using this product ■ take with other drugs containing a NSAID ■ you take more or for a longer time than directed.
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Do not use:
■ if you are allergic to aspirin ■ with any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor ■ with any other product containing acetaminophen
- Ask doctor before using if you have:
- Ask a doctor or pharmacist before use if
- When using this product do not exceed recommended dose.
- Stop use and ask a doctor if
- If pregnant or breast-feeding a baby,
- KEEP OUT OF REACH OF CHILDREN.
- Directions:
- Other Information:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER
extra strength pain reliever tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-242 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange (Rose Orange) Score no score Shape ROUND Size 11mm Flavor Imprint Code FR2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71105-242-68 100 in 1 CARTON; Type 0: Not a Combination Product 10/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/01/2017 Labeler - Redicare LLC (800149346)