Rugby Cough SYRUP Guaifenesin, 4 fl oz (118 mL)

Manufacturer: Unit Dose Services
Effective date: 2019-01-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:58:07

Label at a glance#

ProductRugby Cough Guaifenesin

Active ingredientGUAIFENESIN

Label structure12 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-hour period • measure only with dosing cup provided • keep dosing cup with product • mL=milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL-20 mL every 4 hours children under 12 years do not use

Storage and handling

• each 10 mL contains: sodium 4 mg • store at 20-25°C (68-77°F). • alcohol-free

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-467-2748

Websitewww.rugbylaboratories.com

www.rugbylaboratories.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 200 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

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 last more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
mL=milliliter
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	10 mL-20 mL every 4 hours
children under 12 years	do not use

Other information

STORAGE AND HANDLING SECTION

each 10 mL contains:sodium 4 mg
store at 20-25°C (68-77°F).
alcohol-free

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Re-order No.370448

Rev.10/15

R-107

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50436-1095

NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE

RUGBY COUGH SYRUP GUAIFENESIN (GUAIFENESIN) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	2
310604	guaifenesin 20 MG/ML Oral Solution	SCD	2
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	2
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	2
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	2
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	2
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-1095-1	2021-01-29	C162847	48780-1	ba0f9c33-56ca-a910-e053-dadaa90a0b85	Rugby Cough SYRUP Guaifenesin, 4 fl oz (118 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-1095-1	Rugby Cough Guaifenesin	118 in 1 BOTTLE	LIQUID	118		2
50436-1095-1	Rugby Cough Guaifenesin	1 mL in 1 CARTON	LIQUID	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-1095	RUGBY COUGH GUAIFENESIN (GUAIFENESIN) LIQUID [UNIT DOSE SERVICES]	2	Legacy NDC, 2 package rows	20190109_7486c5ae-3e00-4c9f-bcb7-047a90af0f94.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-1095-1	ML - Milliliter	50436-1095	9625a902-baf3-4a93-bbaf-6f704ff83109	1	2019-02-13
0536-1095-97	ML - Milliliter	0536-1095	5faff7d5-2627-4902-b673-5f72940c45ec	1	2016-07-19

Products#

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

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

Rugby Cough Guaifenesin
Guaifenesin
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
POTASSIUM CITRATE
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SUCRALOSE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50436-1095	50436-1095-1
0536-1095

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
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
POTASSIUM CITRATE	EE90ONI6FF	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
XANTHAN GUM	TTV12P4NEE	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fe47f81a-63a6-4c4d-91dc-88a0e32df57b			7486c5ae-3e00-4c9f-bcb7-047a90af0f94	2019-01-08	Warnings	Exact identifier spl id: fe47f81a-63a6-4c4d-91dc-88a0e32df57b spl set id: 7486c5ae-3e00-4c9f-bcb7-047a90af0f94

Reported adverse events (FAERS/openFDA)#

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