NDC | 69103-2507-5, 69103-2507-6 |
Set ID | 54b10f1d-8988-4f2f-88f8-49ee9d2cb96e |
Category | HUMAN OTC DRUG LABEL |
Packager | Provision Medical Products |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- 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
-
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 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69103-2507-6 100 in 1 CARTON 04/03/2015 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 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)