AcetaFlu DayTime

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 DayTime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each packet)                                                                   Purposes

Acetaminophen 650 mg.............................................................................Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg.....................................................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 packets 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

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 use more than directed
• take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor

Age Dose

children under 4 years of age                                     do not use
children 4 to under 12 years of age                            do not use unless directed by a doctor
adults and children 12 years of age and over               one packet

• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 – 15 minutes.

• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating.
Do not overheat.

SPL UNCLASSIFIED SECTION

Other information
• each packet contains: sodium 20 mg
• store at controlled room temperature 20-25ºC (68-77ºF). Protect from excessive heat and moisture.

INACTIVE INGREDIENT SECTION

Inactive ingredients

sodium citrate, mannitol, aspartame, hydroxypropyl cellulose, citric acid, tween 80, acesulfame potassium, flavors, sodium bicarbonate

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-838-062022-01-28C16284748780-1d6a99b39-a299-a426-e053-dadaa90af4c2f043e95d-6849-40c5-9247-fd1750bed490

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-838-06AcetaFlu DayTime2 g in 1 PACKETPOWDER21
13411-838-06AcetaFlu DayTime6 in 1 BOXPOWDER61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-838ACETAFLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 2 package rows20200407_f043e95d-6849-40c5-9247-fd1750bed490.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13411-83813411-838-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
ba473176-3949-4851-89bd-504c71e1a9e8f043e95d-6849-40c5-9247-fd1750bed4902020-03-26WarningsExact identifier
spl id: ba473176-3949-4851-89bd-504c71e1a9e8
spl set id: f043e95d-6849-40c5-9247-fd1750bed490

Reported adverse events (FAERS/openFDA)#

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