Label: CAFIZETAMOL FORTE- acetaminophen, caffeine tablet, film coated
- NDC Code(s): 69729-147-40
- Packager: OPMX 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 August 9, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Caffeine warning
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
CAFIZETAMOL FORTE
acetaminophen, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-147 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) STEARIC ACID (UNII: 4ELV7Z65AP) D&C RED NO. 27 (UNII: 2LRS185U6K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color red Score no score Shape OVAL ((Caplet)) Size 17mm Flavor Imprint Code 5431 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-147-40 1 in 1 CARTON 08/09/2023 1 40 in 1 BOTTLE; 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 08/09/2023 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations ELYSIUM PHARMACEUTICALS LIMITED 915664486 label(69729-147) , manufacture(69729-147) , pack(69729-147)