STOP COUGH PLUS- dextromethorphan hydrobromide and guaifenesin tablet

Stop Cough PLUS by

Drug Labeling and Warnings

Stop Cough PLUS by is a Otc medication manufactured, distributed, or labeled by Plus Distributors LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough suppressant

Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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 a doctor before use if you have

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

When using this product,

do not use more than directed.

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent 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 (1-800-222-1222) right away.

Directions

• do not exceed 6 doses in 24 hours
• take with a full glass of water
• adults and children 12 years of age and older
  •  take 1 tablet every 4 hours
• children under 12 years of age: do not use

Other information

• each tablet contains: sodium 20 mg low sodium
• store between 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Principal Display Panel

Mucus relief DM

GUAIFENESIN 400 mg, DEXTROMETHORPHAN HBr 20 mg

EXPECTORANT, COUGH SUPPRESSANT

Controls cough

Thins and loosens mucus

Package Label

Stop Cough PLUS

INGREDIENTS AND APPEARANCE

STOP COUGH PLUS 
dextromethorphan hydrobromide and guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72828-109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	TCL280
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72828-109-30	1 in 1 BOX	02/01/2019
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/01/2019

Labeler - Plus Distributors LLC (116922831)