Rugby® Cough SYRUP

Cough by

Drug Labeling and Warnings

Cough by is a Otc medication manufactured, distributed, or labeled by Lake Erie Medical DBA Quality Care Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COUGH- guaifenesin liquid 
Lake Erie Medical DBA Quality Care Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Rugby®
Cough
SYRUP

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin 100 mg

Uses

helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Warnings

Ask a doctor before use if you have

• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take every four hours
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 2–4 teaspoonfuls
• children 6 to under 12 years: 1–2 teaspoonfuls
• children under 6 years: do not use

Other information

• each teaspoonful contains: sodium 3 mg
• store at room temperature 15°–30°C (59°–86°F)

Inactive ingredients

caramel powder, citric acid, corn syrup, FD&C red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

1-800-645-2158, 9 am – 5 pm ET, Monday – Friday

TAMPER EVIDENT

DO NOT USE IF INNER FOIL SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING

Image of Label

COUGH 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35356-851(NDC: 0536-0825)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Caramel (UNII: T9D99G2B1R)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Corn Syrup (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Menthol (UNII: L7T10EIP3A)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color	brown (Reddish-Brown)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35356-851-04	118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	12/04/2009	10/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/04/2009	10/11/2019

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	RELABEL(35356-851)

Revised: 11/2019

Document Id: 7b00a33e-a469-444a-b429-4da72d62e18f

34390-5

Set id: fd8cc2ed-968d-46c7-9e11-4c6344af78c1

Version: 2

Effective Time: 20191113

 

Lake Erie Medical DBA Quality Care Products LLC