FDA.reportPublic FDA data

Tussin

Manufacturer
Chain Drug Consortium, LLC | AptaPharma, Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:16:29

Label at a glance#

ProductTussin EXPECTORANT
Active ingredientGUAIFENESIN
Label structure13 sections

Indications and uses

Uses helps to loosen phlegm (mucus)and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive

Dosage and administration

Directions do not take more than 6 doses in any 24-hour period Age                                                                            Dose Adults and children 12 years and over                           2 - 4 teaspoonfuls every 4 hours Children under 12 years                                               do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient  
(in each 5 mL tsp)

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

 Purpose

Expectorant

Keep out of reach of children

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.

Uses

INDICATIONS & USAGE SECTION

Uses

helps to loosen phlegm (mucus)and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Warnings

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

When using this product

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 6 doses in any 24-hour period

Age                                                                            Dose
Adults and children 12 years and over                           2 - 4 teaspoonfuls every 4 hours
Children under 12 years                                               do not use

Other information

OTHER SAFETY INFORMATION

Other information

  • Keep carton for full direction for use
  • sodium 3 mg per teaspoonful
  • store between 20-25 ° C (68-77° F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

Caramel, citric acid anhydrous, dextrose, FD and C red # 40, flavor, glycerin, high fructose, corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions?

OTC - QUESTIONS SECTION

Questions? 

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-020-04

Premier Value®
Tussin

Guaifenesin Oral solution, USP

EXPECTORANT


Relieves Chest Congestion
Loosens Mucus
Non-Drowsy

Adult
For ages 12 and Over

Cherry Flavor Liquid

8 FL OZ (37 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

BX-016

AptaPharma Tussin EXP1AptaPharma Tussin EXP1

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-020-042022-12-18C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082022-12-18C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-042022-01-28C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082022-01-28C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-042020-12-31C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082020-12-31C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-042020-01-31C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082020-01-31C16284748780-19d75b9d0-dff0-f424-e053-dadaa90a57cea6ce674a-df4e-4172-8171-bbab0b53c8d2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-020-04ML - Milliliter68016-0209e178b9a-584e-4a73-af1f-0cc3f16cf3b712014-07-02
68016-020-08ML - Milliliter68016-020bbffb260-fb3b-4ed5-82f4-ec3de4b5524612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ6
GUAIFENESINACTIVE MOIETY495W7451VQ6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL6
CARAMELINACTIVE INGREDIENTT9D99G2B1R6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W26
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S6
MENTHOLINACTIVE INGREDIENTL7T10EIP3A6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU6
WATERINACTIVE INGREDIENT059QF0KO0R6

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
68016-02068016-020-04, 68016-020-08

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
GUAIFENESIN495W7451VQACTIB
CARAMELT9D99G2B1RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 290 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2PASTILLE / ORAL826 mgExact identifier — unii candidate
21 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAMUSCULAR101 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii candidate
61 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii candidate
21 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION, EXTENDED RELEASE / ORAL3000 mgExact identifier — unii candidate
3 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2LOZENGE / BUCCALNAExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION/ DROPS / AURICULAR (OTIC)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER / VAGINAL430 mgExact identifier — unii candidate
21 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates

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
6447aba8-f5b0-4b41-9dfa-9923743a001ba6ce674a-df4e-4172-8171-bbab0b53c8d22024-12-29WarningsExact identifier
spl set id: a6ce674a-df4e-4172-8171-bbab0b53c8d2

Reported adverse events (FAERS/openFDA)#

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