CHEST CONGESTION RELIEF DM- dextromethorphan hydrobromide, guaifenesin liquid

Chest Congestion Relief by

Drug Labeling and Warnings

Chest Congestion Relief by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Dextromethorphan HBr, 10 mg

Guaifenesin 100 mg

PURPOSE

Purpose

Cough suppressant

Expectorant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor thoat and bronchial irritation
• helps loosen phlegm (mucus)
• helps thin bronchial secretions to make coughs more productive

WARNINGS

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, 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. 

Do not use ifyou have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

• a cough with too much phlegm (mucus)
• a 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. 

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 (1-800-222-1222) right away

DOSAGE & ADMINISTRATION

Directions

• take every 4 hours as needed, or as directed by a doctor
• do not take moer than 6 doses in 24 hours
• do not exceed recommended dose

• Adults and children 12 years and over: 2 teasponsfuls (10 mL)
• Children under 12 years: do not use

INACTIVE INGREDIENT

Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.

QUESTIONS

1-800-645-2158

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHEST CONGESTION RELIEF  DM
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1313
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  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1313-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2020

Labeler - RUGBY LABORATORIES (079246066)