Label: PAIN TERMINATOR- aspirin, acetaminophen, caffeine, salicylamide tablet
- NDC Code(s): 69103-2507-5, 69103-2507-6
- Packager: Provision Medical Products
- 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 January 5, 2023
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- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
WARNINGS
Warnings:
Reye's syndrome: Children and teenagers should not
use this medicine for chicken pox or u symptoms
before a doctor is consulted about Reye's syndrome, a
rare but serious illness reported to be associated with
aspirin.
Alcohol Warning: If you consume 3 or more
alcoholic drinks every day, ask your doctor whether you
should take acetaminophen and aspirin or other pain
relievers/fever reducers. Acetaminophen and aspirin may
cause liver damage and stomach bleeding.
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 a doctor before using if you have:
• asthma • gastric ulcers • bleeding problems • stomach problems (such as heartburn, upset stomach or stomach pain)
Ask a doctor or pharmacist before use if you are taking a prescription drug for: • anticoagulation (thinning of blood)
• diabetes • gout • arthritis
Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse
• new symptoms occur • redness or swelling is present
When using this product do not exceed
recommended dose.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN TERMINATOR
aspirin, acetaminophen, caffeine, salicylamide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2507 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg Inactive Ingredients Ingredient Name Strength CAFFEINE (UNII: 3G6A5W338E) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color blue (SKY BLUE) 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:69103-2507-5 250 in 1 CARTON 04/03/2015 07/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69103-2507-6 100 in 1 CARTON 04/03/2015 07/01/2024 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 03/31/2015 07/01/2024 Labeler - Provision Medical Products (036936831) Registrant - Provision Medical Products (036936831) Establishment Name Address ID/FEI Business Operations Ultraseal Corporation 085752004 pack(69103-2507) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(69103-2507)
