ACETAFLU COUGH AND CHEST CONGESTION

Manufacturer
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals | S.P.M CORPORATION
Effective date
2020-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:44

Label at a glance#

ProductACETAFLU COUGH AND CHEST CONGESTION
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

do not use more than directed take every 4 hours. Do not take more than 6 packets in 24 hours. Age Dose adults and children 12 years of age and over   one packet  children under 12 years of age do not use  dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. if using microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and afte...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

OTC - PURPOSE SECTION

  • Cough suppressant
  • Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  •  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Do not use

  •  in a child under 12 years of age
  •  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

  •  cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a sodium-restricted diet

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

  • ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


do not use more than directed
take every 4 hours. Do not take more than 6 packets in 24 hours.

AgeDose
adults and children 12 years of age and over  one packet
 children under 12 years of agedo not use 
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. 
  • Do not overheat.

Other information

SPL UNCLASSIFIED SECTION

  •  each packet contains: potassium 12 mg, sodium 51 mg.
  • store at controlled room temperature 20-25°C (68-77°F).

Inactive Ingredients.

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, flavor, lactose, maltodextrin, mannitol, povidone K30, silicon dioxide, sodium bicarbonate, sodium chloride, sodium citrate, sucralose, sucrose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2176267dextromethorphan HBr 20 MG / guaiFENesin 400 MG Powder for Oral SolutionPSN1
2176267dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Powder for Oral SolutionSCD1
2176267dextromethorphan HBr 20 MG / guaifenesin 400 MG Powder for Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-852-06ACETAFLU COUGH AND CHEST CONGESTION5 g in 1 PACKETPOWDER51
13411-852-06ACETAFLU COUGH AND CHEST CONGESTION6 in 1 BOXPOWDER61
13411-852-12ACETAFLU COUGH AND CHEST CONGESTION5 g in 1 PACKETPOWDER51
13411-852-12ACETAFLU COUGH AND CHEST CONGESTION12 in 1 BOXPOWDER121
13411-852-20ACETAFLU COUGH AND CHEST CONGESTION5 g in 1 PACKETPOWDER51
13411-852-20ACETAFLU COUGH AND CHEST CONGESTION20 in 1 BOXPOWDER201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-852ACETAFLU COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR,GUAIFENESIN) POWDER [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 6 package rows20200904_5a6c9b52-255b-48d9-b92e-ded3aa9e29d4.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
13411-85213411-852-06, 13411-852-12, 13411-852-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
2be60640-112d-4b3f-add3-8ffb74ab21a65a6c9b52-255b-48d9-b92e-ded3aa9e29d42020-08-31WarningsExact identifier
spl id: 2be60640-112d-4b3f-add3-8ffb74ab21a6
spl set id: 5a6c9b52-255b-48d9-b92e-ded3aa9e29d4

Reported adverse events (FAERS/openFDA)#

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