COUGH- guaifenesin liquid

Cough by

Drug Labeling and Warnings

Cough by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 2 TSP (10mL))

Guaifenesin USP 200 mg

Purpose

Expectorant

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Warnings

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.

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. 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

• this product is not intended for use in children under 12 years of age
• TSP=teaspoonful
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 2–4 TSP every 4 hours
• children under 12 years: do not use

Other information

• each teaspoonful (5 mL) contains: sodium 3 mg
• store at 20°–25°C (68°–77°F). Alcohol free. Do not refrigerate.

Inactive ingredients

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

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Rugby ®
NDC: 0536-0825-85

Compare to
Active Ingredient in
Robitussin® Mucus Plus
Chest Congestion*

Alcohol-Free Non-Narcotic
Expectorant

Cough
Syrup

(Guaifenesin Syrup, USP)

TAMPER EVIDENT: DO NOT USE IF
INNER FOIL SEAL OVER MOUTH OF
BOTTLE IS BROKEN OR MISSING.

This is a bulk package, not intended for
households with young children.
Dispense contents with a child-resistant
closure in a tight, light-resistant
container as defined in the USP.

One Pint (473 mL)

INGREDIENTS AND APPEARANCE

COUGH 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (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: 0536-0825-97	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2009	10/31/2017
2	NDC: 0536-0825-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2009	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/04/2009	08/31/2020

Labeler - Rugby Laboratories Inc. (079246066)