FDA.reportPublic FDA data

Akin Expectorant Formula Strawberry Banana

Manufacturer
Southern Sales & Service, Inc.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:03

Label at a glance#

ProductAkin Expectorant Formula Strawberry Banana
Active ingredientGUAIFENESIN
Label structure7 sections

Indications and uses

• 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 hours period Adults and children 12 years and over Take 2-4 teaspoonful (5mL) every 4 hours Children under 12 years Consult a physician

Label contents#

Full prescribing information#

Active ingredient (in each 5ml tsp.)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm(mucus) unless direct by a doctor."

Stop use and ask a doctor if

OTC - STOP USE SECTION

• cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistant headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If pregnant or beast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health 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 take more than 6 doses in any 24 hours period

Adults and children 12 years and overTake 2-4 teaspoonful (5mL) every 4 hours
Children under 12 yearsConsult a physician

Other information

SPL UNCLASSIFIED SECTION

• store at room temperature • 15°-30°C (59°-86°F)

Do not use if seal under cap is torn, broken or missing. TAMPER-EVIDENT:

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-212-04Akin Expectorant Formula Strawberry Banana118 mL in 1 BOTTLELIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-212AKIN EXPECTORANT FORMULA STRAWBERRY BANANA (GUAIFENESIN) LIQUID [SOUTHERN SALES & SERVICE, INC.]2Current NDC, 1 package rows20231201_b63b0133-d2da-432b-a154-9e77535bbef9.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-21269822-212-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
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 Expectorant Formula Strawberry BananaGUAIFENESINSouthern Sales & Service, Inc.b63b0133-d2da-432b-a154-9e77535bbef92023-11-29WarningsExact identifier
ndc (package): 69822-212-04
ndc (product): 69822-212
ndc11 (package): 69822021204
spl id: 0b57d778-6038-5046-e063-6294a90ab89e
spl set id: b63b0133-d2da-432b-a154-9e77535bbef9

Reported adverse events (FAERS/openFDA)#

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