ROBO COUGH- dextromethorphan hbr liquid

Robo Cough by

Drug Labeling and Warnings

Robo Cough by is a Otc medication manufactured, distributed, or labeled by DXM Pharmaceutical, Inc., Monarch PCM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

In each 3ml (one dose)

Dextromethrophan HBr 30 mg......................cough suppressant

INDICATIONS & USAGE

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

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 MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have

• a cough that is accompanied by excessive phlegm (mucus), or
• a persisten or chronic cough such as occurs with smoking, asthma, or emphysema.

STOP USE

Stop use and ask a doctor if​ a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION

​Directions

• ​only use this product according to these directions or as directed by a doctor.
• do not exceed 120 milligrams in any 24-hour period
• measure only 3mL with dosing cup provided
• keep dosing cup with product
• mL= milliliter
• this adult product is not intented for use in children under 12 years of age.

• age: dose
• adults and children 12 years and over:

  3mL every 6 to 8 hours

• children under 12 years: do not use

STORAGE AND HANDLING

Other information

• ​​store at 20-25* (68-77*F). Do not refrigerate.
• TAMPER EVIDENT: Do not use if printed shrink band on bottle is broken or missing.

INACTIVE INGREDIENT

​Inactive ingredients​ high fructose corn syrup, phosphoric acid, propylene glycol, purified water, sodium benzoate (preservative), sucralose

QUESTIONS

​Questions or comments?

​Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.

ACTIVE INGREDIENT

Dextromethorphan HBr........30mg

PRINCIPAL DISPLAY PANEL

Distributed by:

DXM Pharmaceutical, Inc.

2717 Commercial Center Blvd.,

Suite E200

Katy, TX 77494

www.RoboCough.com

Patent Pending. Copyright 2018 DXM Pharmaceutical, Inc.

INGREDIENTS AND APPEARANCE

ROBO COUGH 
dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71598-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71598-001-45	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2019

Labeler - DXM Pharmaceutical, Inc. (080748277)

Registrant - DXM Pharmaceutical, Inc. (080748277)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM, LLC		080000294	manufacture(71598-001)