EXTRA ACTION COUGH- guaifenesin and dextromethorphan hydrobromide liquid

Extra action Cough by

Drug Labeling and Warnings

Extra action 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

Active ingredients (in each 2 teaspoonfuls (10 mL))	Purposes
Dextromethorphan HBr USP 20 mg	Cough Suppressant
Guaifenesin USP 200 mg	Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• cough 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 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

• do not take more than 6 doses in any 24-hour period
• this product is not intended for use in children under 12 years of age

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

Other information

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

Inactive Ingredients

Artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, 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 USA

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

COMPARE TO
ACTIVE INGREDIENTS IN
ROBITUSSIN ® COLD COUGH+CHEST
CONGESTION DM*

Rugby ®

NDC: 0536-0970-85

Non-narcotic Cough Suppressant
and Expectorant

EXTRA ACTION

Cough Syrup

(Guaifenesin with
Dextromethorphan HBr Syrup)

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.

*Rugby Laboratories is not affiliated with the owner
ROBITUSSIN ® COLD COUGH+CHEST CONGESTION DM

Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive,
Suite 233
Livonia, MI 48152 USA
www.rugbylaboratories.com

One Pint (473 mL)

Re-order No. 370054
Rev. 03/17
R-64

INGREDIENTS AND APPEARANCE

EXTRA ACTION COUGH 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-0970
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
CHERRY (UNII: BUC5I9595W)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	pink (Reddish-Pink)	Score
Shape		Size
Flavor	MENTHOL, CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-0970-97	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2011	03/30/2020
2	NDC: 0536-0970-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2011	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/03/2011	05/31/2020

Labeler - Rugby Laboratories Inc. (079246066)