Active Ingredient
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
Acetaminophen Phenylephrine Hcl
FDA Label NDC 69168-261
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Acetaminophen Phenylephrine Hcl (NDC 69168-261). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask doctor before use if you have, ask doctor/pharmacist before use if you, when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Nasal decongestant
Uses
temporarily relieves nasal and sinus congestion temporarily relieves minor aches and pains, headaches
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
When Using
do not use more than directed
Stop Use And Ask A Doctor If
redness or swelling is presentnew symptoms occur you get nervous, dizzy, or sleepless pain gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 daysYou may report side effects to 800-952-0050
If Pregnant Or Breast Feeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
Adults and children 12 years of age and older: take 2 tablets every 4-6 hours Do not take more than 8 tablets in 24 hours Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems
Other Information
store at room temperature in a dry place do not use if blister package is torn
Inactive Ingredients
corn starch, crospovidone, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
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