Label: ACETAMINOPHEN PHENYLEPHRINE HCL- acetaminophen 500mg phenylephrine hcl 5mg tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69168-261-99 - Packager: Allegiant Health
- 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 September 16, 2014
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Warnings
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 with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
Do Not Use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask Doctor before use if you have
liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland
Ask Doctor/Pharmacist before use if you
are taking the blood thinning drug warfarin
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN PHENYLEPHRINE HCL
acetaminophen 500mg phenylephrine hcl 5mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-261 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code AZ;261 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-261-99 23437 in 1 CARTON; 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 12/01/2014 Labeler - Allegiant Health (079501930) Registrant - Allegiant Health (079501930) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 ANALYSIS(69168-261) , LABEL(69168-261) , MANUFACTURE(69168-261) , PACK(69168-261) , RELABEL(69168-261) , REPACK(69168-261)