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Acetaminophen Phenylephrine HCl

Medically reviewed on September 18, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Allegiant Health
NDC Code: 69168-261

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 Facts

Active ingredient

Acetaminophen 500 mg
Phenylephrine HCl 5 mg

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

Package/Label Principal Display Panel
ACETAMINOPHEN PHENYLEPHRINE HCL 
acetaminophen 500mg phenylephrine hcl 5mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-261
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeAZ;261
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-261-9923437 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/01/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-261), LABEL(69168-261), MANUFACTURE(69168-261), PACK(69168-261), RELABEL(69168-261), REPACK(69168-261)

 
Allegiant Health

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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