Label: PAIN RELIEVER 2- pain reliever tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 71105-174-02, 71105-174-68 - Packager: Redicare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 July 2, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Uses:
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Warnings:
Reye’s syndrome: Children and teenagers should not use this medicine for chickenpox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.
Liver Warning
This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.
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 an NSAID ■ you take more or for a longer time than directed.
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 ■ with large amounts of caffeinated products
Ask a doctor before use if you have:
■ asthma, liver, kidney, high blood pressure or heart disease ■ stomach problems (such as heartburn, upset or painful stomach) ■ gastric ulcers ■ bleeding problems ■ taking a diuretic ■ or if the stomach bleeding warning applies to you
Ask a doctor or pharmacist before use if
you are taking a prescription drug for ■ anticoagulation (thinning of blood) ■ diabetes ■ gout ■ arthritis ■ with other drugs or conditions
Stop use and ask a doctor if:
■ ringing in the ears or loss of hearing occurs ■ pain or fever persists or worsens ■ new symptoms occur ■ allergic reaction, redness or swelling is present
- Directions:
- Other Information:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER 2
pain reliever tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-174 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STEARIC ACID (UNII: 4ELV7Z65AP) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code fr9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71105-174-68 50 in 1 BOX 01/03/2020 1 NDC:71105-174-02 2 in 1 PACKAGE; 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 01/03/2020 Labeler - Redicare LLC (800149346)