DRUG FACTS

Manufacturer
Bryant Ranch Prepack
Effective date
2026-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-27 02:02:23

Label at a glance#

ProductFoster and Thrive Chest Congestion Relief DM DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections

Indications and uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■ Helps make coughs more productive.

Storage and handling

Store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient - (per tablet)

Dextromethorphan Hydrobromide   20mg

Guaifenesin  400mg

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.

Warnings

WARNINGS SECTION

Do not use  ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

OTC - ASK DOCTOR SECTION

Ask doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ cough is accompanied by excessive phlegm (mucus)

OTC - STOP USE SECTION

Stop use and ask doctor if
■ symptoms are accompanied by fever, rash or persistent headache
■ cough persists for more than 1 week or tends to recur.
A persistent cough may be a sign 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 Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions
■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
■ Children under 6 years of age: consult a doctor.   
Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

HOW SUPPLIED

How Supplied Section

Guaifenesin and Dextromethorphan Hydrobromide 400mg/20mg Tablets

  • NDC 71335-3187-1: 30 Tablets in a BOTTLE
  • NDC 71335-3187-2: 20 Tablets in a BOTTLE
  • NDC 71335-3187-3: 18 Tablets in a BOTTLE
  • NDC 71335-3187-4: 60 Tablets in a BOTTLE

Store at 15°-30°C (59°-86°F)

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin and Dextromethorphan Hydrobromide 400mg/20mg Tablets

Label
Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00371335318710(21)0123456789(17)281015(10)208820GTIN-14: 00371335318710
GTIN-12: 371335318710
UPC-A: 371335318710
EAN-13: 0371335318710
GTIN storage (14 digits): 00371335318710
lbl713353187.jpg
QR code linkQR Codedailymed.nlm.nih.gov/dailymed/search.cfm?adv=1&query=NDC:71335-3187-1lbl713353187.jpg
Data codeCode 1287133531871lbl713353187.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1055-1EA - Each70677-1055ed67222b-278e-4996-93fe-72d2e32b606c12023-09-05

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-318771335-3187-1
70677-1055

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
Foster and Thrive Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC5372f764-985e-4a42-bc97-cb0dc90fcd9c2024-12-18WarningsExact identifier
ndc (product): 70677-1055

Reported adverse events (FAERS/openFDA)#

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