Label: ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG tablet
- 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 November 16, 2020
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- ACTIVE INGREDIENT
ammonium hydroxide, croscarmellose sodium, D&C red No. 33 aluminum lake, ethyl cellulose, FD&C blue No. 1 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, light mineral oil, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch, propylene glycol, shellac glaze, sorbitol sorbitan, talc, titanium dioxide, triacetin
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 gelcaps in 24 hours, which is the maximum daily amount for this product, with other drugs contains acetaminophen, 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions or severe allergic reactions. Symptoms may include: skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), shock. If a skin or general allergic 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, if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have liver disease, glaucoma, difficulty in urination due to enlargement of the prostate gland, a breathing problem such as emphysema or chronic bronchitis.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin, taking sedatives or tranquilizers.
When using this product, you may get drowsy, avoid alcoholic drinks, excitability may occur, especially in children, alcohol, sedatives, and tranquilizers may increase drowsiness, be careful when driving a motor vehicle or operating machinery, limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if new symptoms occur, redness or swelling is present, pain gets worse or lasts for more than 10 days, fever gets worse or lasts for more than 3 days.
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG
acetaminophen 500mg caffeine 60mg pyrilamine maleate 15mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-146 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSES (UNII: 3NXW29V3WO) D&C RED NO. 33 (UNII: 9DBA0SBB0L) GLYCERIN (UNII: PDC6A3C0OX) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LIGHT MINERAL OIL (UNII: N6K5787QVP) POVIDONE (UNII: FZ989GH94E) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) TRIACETIN (UNII: XHX3C3X673) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color blue (DARK BLUE and LIGHT BLUE) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code S79 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-146-22 12 in 1 PACKAGE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2020 Labeler - OPMX LLC (029918743)