COUGH AND CONGESTION DM- dextromethorphan and guaifenesin capsule, liquid filled

Cough and Congestion DM by

Drug Labeling and Warnings

Cough and Congestion DM by is a Otc medication manufactured, distributed, or labeled by Agile Pharmachem. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each liquid filled capsule)

Dextromethorphan Hydrobromide, USP 10mg

Guaifenesin, USP 200mg

Purpose

Cough Suppressant

Expectorant

Uses

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

Directions

• Do not take more than 12 capsules in any 24 hour period
• This adult product is not intend for use in children under 12 years of age
  • Age: dose
  • Adults and children 12 years and over: 2 capsules every 4 hours
  • Children under 12 years: Do not use

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

• cough that occurs with too much phlegm(mucus)
• cough that lasts or is chronic such as occur 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 persistent headache. This 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.

Other Information

• store at 20-25 °C(68-77 °F)
• avoid excessive heat above 40 °C (104°F)

Inactive Ingredients

FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

Questions or Comments

Toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough and Congestion DM,

NDC: 58805-007-75  25*300 Softgel Liquid filled

INGREDIENTS AND APPEARANCE

COUGH AND CONGESTION DM 
dextromethorphan and guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58805-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POVIDONE (UNII: FZ989GH94E)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED (Light)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	601
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58805-007-75	7500 in 1 CAPSULE
1		1 in 1 CARTON; 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	11/08/2015

Labeler - Agile Pharmachem (650687853)

Registrant - Agile Pharmachem (650687853)