NDC | 35418-242-02, 35418-242-67, 35418-242-68, 35418-242-69 |
Set ID | f053c2eb-87ab-43c8-9cea-8754f44525b0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Zee Medical Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
WARNINGS
Liver Warning: This product contains acetaminophen. Severe liver damage
may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
• 3 or more alcoholic drinks every day while using this product
______________________________________________________________
Do not use:
• with any other product containing acetaminophen this will provide more
than the recommended dose (overdose) of acetaminophen and could
cause serious health concerns.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• When using this product do not exceed recommended dose.
_______________________________________________________________
Stop use and ask a doctor if:
• symptoms do not improve
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZEE PAIN AID
acetaminophen salicylamide aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-242 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color orange (light orange) Score no score Shape ROUND (PA;ZEE) Size 11mm Flavor Imprint Code PA;ZEE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35418-242-69 500 in 1 CARTON 06/12/2012 1 NDC:35418-242-68 50 in 1 CARTON 1 NDC:35418-242-67 125 in 1 CARTON 1 NDC:35418-242-02 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 06/12/2012 Labeler - Zee Medical Inc (009645623) Registrant - Zee Medical Inc (009645623) Establishment Name Address ID/FEI Business Operations Ultratab Laboratories, Inc. 151051757 manufacture(35418-242) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(35418-242)