Label: ADULTS ACETAMINOPHEN AND CAFFEINE PAIN RELIEVER FEVER REDUCER- acetaminophen, caffeine tablet
- NDC Code(s): 62049-002-00
- Packager: Genvion Corporation
- 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.
Updated December 16, 2019
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- Drug Facts
- Active ingredients (in each tablet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 tablets in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.
Do not use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
Stop use and ask a doctor if
• new symptoms occur • redness or swelling is present. These could be signs of a serious condition.
- Other information
Colloidal Silicon Dioxide, Cornstarch, Ethylparaben, FD&C Red No. 40, FD&C Yellow No. 6, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Propylparaben, Sodium Carboxymethyl Starch, Sodium Starch Glycolate, Stearic Acid, Sucralose, Talc, Titanium Dioxide
- Package Labeling:
INGREDIENTS AND APPEARANCE
ADULTS ACETAMINOPHEN AND CAFFEINE PAIN RELIEVER FEVER REDUCER
acetaminophen, caffeine tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62049-002 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) ETHYLPARABEN (UNII: 14255EXE39) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape ROUND Size 12mm Flavor Imprint Code 104 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62049-002-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/05/2016 Labeler - Genvion Corporation (245221226)