Label: VICA-CET- acetaminophen, caffeine,magnesium salicylate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69103-2550-6 - Packager: Provision Medical Products
- Category: HUMAN OTC DRUG LABEL
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 April 5, 2015
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- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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.
Allergy Alert: Do not take this product if after
taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock
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.
Ask a doctor before use if you have: • the worst headache of your life • ulcers
• fever and sti neck • asthma
• bleeding problems • liver disease
• renal disease
When using this product:
• limit the use of caffeine containing medications,
foods, or beverages while taking this product
because too much caFFeine may cause
nervousness, sleeplessness, irritability and,
occasionally, rapid heart beat.
Stop use and ask a doctor if:
• headache pain worsens or continues for more than 48 hours
• new or unexpected symptoms occur
• ringing in the ears or loss of hearing occur
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VICA-CET
acetaminophen, caffeine,magnesium salicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2550 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 250 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength CAFFEINE (UNII: 3G6A5W338E) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color white (SNOW WHITE) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR32 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69103-2550-6 100 in 1 CARTON 04/03/2015 1 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 04/03/2015 Labeler - Provision Medical Products (036936831) Registrant - Provision Medical Products (036936831) Establishment Name Address ID/FEI Business Operations Ultraseal Corporation 085752004 pack(69103-2550) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(69103-2550)