CHEST CONGESTION RELIEF- guaifenesin and dextromethorphan hbr tablet

Chest Congestion Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

(in each intermediate release tablet)

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Purpose

Expectorant

Cough Suppressant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
• helps loosen phelgm (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 your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• cough accompanied by too much of phelgm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• when using this product do not use more than directed

Stop use and ask 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 right away. (1-800-222-1222)

Directions

• take with full glass of water;

  1 tablet every 4 hours

• do not take more than 6 tablets in 24 hours
• children under 12 years: do not use

Other Information

• store at 25° C(77°F) ; excursion permitted between 15°-30° C (59°-86°F)
• see end flap for expiration date and lot number
• metal content per tablet:
• sodium 7mg, Magnesium 1mg

Inactive Ingredients

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline cellulose, Magnesium stearate, Polyethylene Glycol, Stearic Acid powder, Sodium Starch Glycolate

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70677-0012-1

INGREDIENTS AND APPEARANCE

CHEST CONGESTION RELIEF 
guaifenesin and dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-0012
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	TCL;280
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-0012-1	50 in 1 BOTTLE	11/25/2016
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	11/25/2016

Labeler - Mckesson (177667227)