FDA.reportPublic FDA data

Akin Cough Formula DM

Manufacturer
Southern Sales & Service, Inc.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:02:58

Label at a glance#

ProductAkin Cough Formula DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Indications and uses

temporarily quiets cough associated with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage and administration

Do not take more than 6 doses in any 24 hour period adults and children 12 years and over 10 ml (2 teaspoonfuls every 4 hours or as directed by doctor) Children under 12 years do not use

Label contents#

Full prescribing information#

(in each 5ml tsp.) Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr USP 10 mg Guaifenesin USP 100 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily quiets cough associated with the common cold or inhaled irritants

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough occurs with too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

Cough lasts for 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the 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 take more than 6 doses in any 24 hour period

adults and children 12 years and over10 ml (2 teaspoonfuls every 4 hours or as directed by doctor)
Children under 12 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • 15°- 30°C (59°- 86°F)
  • TAMPER-EVIDENT: Do not use if seal under cap is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potassium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD&C Red#40, purified Water.

Akin Cough Formula DM 118 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Updated LabelUpdated Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN9
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY9
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY9

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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-201-042022-08-24C16284748780-19d75b9d0-8374-f424-e053-dadaa90a57ceAkin Cough Formula DM
69822-201-042022-01-28C16284748780-19d75b9d0-8374-f424-e053-dadaa90a57ceAkin Cough Formula DM
69822-201-042020-02-11C16284748780-19d75b9d0-8374-f424-e053-dadaa90a57ceAkin Cough Formula DM
69822-201-042020-01-31C16284748780-19d75b9d0-8374-f424-e053-dadaa90a57ceAkin Cough Formula DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-202-04Akin Cough Formula DM118 mL in 1 BOTTLELIQUID1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-202AKIN COUGH FORMULA DM (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [SOUTHERN SALES & SERVICE, INC.]9Current NDC, Legacy NDC, 1 package rows20231201_1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a.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
69822-20269822-202-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM CITRATE1Q73Q2JULRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
CHERRYBUC5I9595WIACT
MENTHOLL7T10EIP3AIACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

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
Akin Cough Formula DMDEXTROMETHORPHAN, GUAIFENESINSouthern Sales & Service, Inc.1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a2023-11-29WarningsExact identifier
ndc (package): 69822-202-04
ndc (product): 69822-202
ndc11 (package): 69822020204
spl id: 0b57eba9-b690-4dfa-e063-6294a90a06e2
spl set id: 1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a

Reported adverse events (FAERS/openFDA)#

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