Rugby Chest Congestion Relief

Manufacturer
Bryant Ranch Prepack
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
102
Source
full-release
Hydrated at
2026-06-01 00:56:12

Label at a glance#

ProductRugby Chest Congestion Relief 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 400 mg/20 mg Tablets

  • NDC 71335-2216-1: 30 Tablets in a BOTTLE
  • NDC 71335-2216-2: 20 Tablets in a BOTTLE
  • NDC 71335-2216-3: 18 Tablets in a BOTTLE
  • NDC 71335-2216-4: 60 Tablets in a BOTTLE

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin and Dextromethorphan Hydrobromide 400mg/20mg Tablet

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN102
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD102
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY102

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2216-1Rugby Chest Congestion ReliefDM30 in 1 BOTTLETABLET30102
71335-2216-2Rugby Chest Congestion ReliefDM20 in 1 BOTTLETABLET20102
71335-2216-3Rugby Chest Congestion ReliefDM18 in 1 BOTTLETABLET18102
71335-2216-4Rugby Chest Congestion ReliefDM60 in 1 BOTTLETABLET60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2216RUGBY CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [BRYANT RANCH PREPACK]102Current NDC, 4 package rows20250228_7b23faa9-40c8-4cea-b9fb-487cce2664af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1312-08EA - Each0536-1312c5838f8c-3827-49d1-9774-f98f4dbeeade12021-08-05

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
71335-221671335-2216-1, 71335-2216-2, 71335-2216-3, 71335-2216-4
0536-1312

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack7b23faa9-40c8-4cea-b9fb-487cce2664af2025-01-31WarningsExact identifier
ndc (package): 71335-2216-2
ndc (package): 71335-2216-4
ndc (package): 71335-2216-3
ndc (package): 71335-2216-1
ndc (product): 71335-2216
ndc11 (package): 71335221603
ndc11 (package): 71335221601
ndc11 (package): 71335221604
ndc11 (package): 71335221602
spl id: c9d9d4bf-2fb0-44d4-b3fa-b16457faf413
spl set id: 7b23faa9-40c8-4cea-b9fb-487cce2664af
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRugby Laboratories5da36516-9f94-49cb-9421-0c310abcd1162024-12-18WarningsExact identifier
ndc (product): 0536-1312

Reported adverse events (FAERS/openFDA)#

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