AcetaFlu NightTime Effervescent

Manufacturer
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals | S.P.M CORPORATION
Effective date
2020-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:16

Label at a glance#

ProductAcetaFlu NightTime Effervescent
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)                                                                         Purposes

Acetaminophen 650 mg.................................................................................Pain reliever/fever reducer
Diphennhydramine Hydrochloride 25 mg.........................................................Antihistamine/ Cough suppressant
Phenylephrine Hydrochloride 10 mg................................................................Nasal decongestant

INDICATIONS & USAGE SECTION

Uses
• temporarily relieves these symptoms due to a cold:
• minor aches and pains • minor sore throat pain • headache
• nasal and sinus congestion • cough due to minor throat and bronchial irritation
• temporarily reduces fever

WARNINGS SECTION

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 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
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use • in a child under 12 years of age • if you are allergic to acetaminophen
• 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 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.

Ask a doctor before use if you have
• liver disease • heart disease • high blood pressure • thyroid disease • diabetes
• trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin

When using this product • do not exceed recommended dosage. avoid alcoholic drinks marked drowsiness may occur.

Alcohol, sedatives and tranquilizes may increase drowsiness be careful when driving a motor vehicle or operating machinery

excitability may occur, especially with children.

Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days
• redness or swelling is present • new symptoms occur • symptoms do not get better or worsen
• pain, cough or nasal congestion gets worse or lasts more than 7 days
• cough comes back or occurs with fever, rash or headache that lasts. These could be signs or serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is
critical for adults as well as children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions
• do not take more than the the recommended dose
• adults and children 12 years and over: take 1 tablet fully dissolved in 8 oz of water every 4 hours. Do not exceed 6 tablets in 24 hours or as directed by a doctor
• children under 12 years: do not use

SPL UNCLASSIFIED SECTION

Other information
• each tablet contains: sodium 272 mg
• store at room temperature. Avoid excessive heat .

INACTIVE INGREDIENT SECTION

Inactive ingredients

mannitol, aspartame, kollidon 30, citric acid, tween 20, sodium citrate, sodium bicarbonate, sodium carbonate, flavors, polyethylene glycol,

dimethicone

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287739acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Effervescent Oral TabletPSN1
2287739acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Effervescent Oral TabletSCD1
2287739acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Effervescent Oral TabletSY1
2287739APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Effervescent Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-841-162022-01-28C16284748780-1d6a99b39-88b2-a426-e053-dadaa90af4c2d5ebda54-8917-4bd7-af47-354432f13cc8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-841-16AcetaFlu NightTime Effervescent4 in 1 BLISTER PACKTABLET, EFFERVESCENT41
13411-841-16AcetaFlu NightTime Effervescent4 in 1 BOXTABLET, EFFERVESCENT41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-841ACETAFLU NIGHTTIME EFFERVESCENT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 2 package rows20200407_d5ebda54-8917-4bd7-af47-354432f13cc8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13411-84113411-841-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
106498d1-31cc-41e7-a17b-9463fbeb6cb1d5ebda54-8917-4bd7-af47-354432f13cc82020-03-26WarningsExact identifier
spl id: 106498d1-31cc-41e7-a17b-9463fbeb6cb1
spl set id: d5ebda54-8917-4bd7-af47-354432f13cc8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.