FDA.reportPublic FDA data

Foster and Thrive Cough and Chest Congestion DM Sugar Free Cough Syrup

Manufacturer
Strategic Sourcing Service, LLC | Weeks & Leo Co., Inc.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:45:15

Label at a glance#

ProductTussin DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to: drain bronchial tubes make coughs more productive rid bronchial passageways of bothersome mucus temporarily relieve cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Dosage and administration

take every 4 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 40 mL every 4 hours children under 12 years do not use

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to:
  • drain bronchial tubes
  • make coughs more productive
  • rid bronchial passageways of bothersome mucus
  • temporarily relieve cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings

WARNINGS SECTION

Do not use 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.

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts for more than 1 week, comes back, or occurs with a fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over40 mL every 4 hours
children under 12 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • store at 20º C to 25º C (68º F 77º F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid (anhydrous), flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, triacetin, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call (833) 358-6431 Monday - Friday 9 am - 7 pm EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Foster & Thrive

Adult

Tussin DM

Dextromethorphan HBr

Guaifenesin

Cough Suppressant

Expectorant

Cough & Chest Congestion DM

Alcohol Free Dye Free Sugar Free

  • Relieves chest congestion
  • Controls cough
  • Thins & loosens mucus

8 FL OZ (237 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN3
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD3
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY3
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY3
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY3

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1185-1Tussin DM1 in 1 CARTONSYRUP13
70677-1185-1Tussin DM118 mL in 1 BOTTLESYRUP1183
70677-1185-2Tussin DM1 in 1 CARTONSYRUP13
70677-1185-2Tussin DM236 mL in 1 BOTTLESYRUP2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1185TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SYRUP [STRATEGIC SOURCING SERVICE, LLC]3Current NDC, 4 package rows20241222_0b6689db-ea34-9a06-e063-6394a90abaf7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1185-1ML - Milliliter70677-118514a0c186-3465-4cfb-bf4d-417d464e10e512024-03-12
70677-1185-2ML - Milliliter70677-1185f32c87e9-4095-43a5-9269-f699559e19fb12024-03-12

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-118570677-1185-2, 70677-1185-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRIACETINXHX3C3X673IACT
SODIUM GLUCONATER6Q3791S76IACT
XANTHAN GUMTTV12P4NEEIACT

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
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Service, LLC0b6689db-ea34-9a06-e063-6394a90abaf72024-12-19WarningsExact identifier
ndc (package): 70677-1185-2
ndc (package): 70677-1185-1
ndc (product): 70677-1185
ndc11 (package): 70677118502
ndc11 (package): 70677118501
spl id: 29a16fb2-7764-2cd6-e063-6294a90a90e5
spl set id: 0b6689db-ea34-9a06-e063-6394a90abaf7

Reported adverse events (FAERS/openFDA)#

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