CHEST CONGESTION AND COUGH RELIEF DM- dextromethorphan hbr, guaifenesin capsule, liquid filled

Chest Congestion and Cough Relief DM by

Drug Labeling and Warnings

Chest Congestion and Cough Relief DM by is a Otc medication manufactured, distributed, or labeled by ARMY AND AIR FORCE EXCHANGE SERVICE, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients (per softgel)
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

PURPOSE

Purposes
Dextromethorphan HBr ..........................Cough Suppressant
Guaifenesin       ....................................Expectorant

INDICATIONS & USAGE

Uses
■ helps loosen phlegm (mucus) and thin broochial secretions to make cough more
   productlve
■ temporarily relieves cough due to minor throat and bronchial irritation as may
  occur with a cold

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), or for two 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
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic such as occurs with smoking, asthma, chronic
   bronchitis or emphysema

STOP USE

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is
accompanied by fever, rash, or persistent headache. 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 right away.

DOSAGE & ADMINISTRATION

Directions
■ Do not take more than 12 softgels in any 24·hour period
■ This product is nol lntended for use in children under 12 years
■ Adults & children 12 years and over - 2 softgels every 4 hours
■ Children under 12 years of age - do not use

OTHER SAFETY INFORMATION

Other information
■ Store at room temperature
■ Avoid excessive heat above 40'C (104'F)

INACTIVE INGREDIENT

Inactive ingredients
FD&C Red # 40, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene
glycol, Purified water, Sorbitol sorbllan solulion, Titanium dioxide

QUESTIONS

Questions? 1-877-798-5944

Product Label: exchange select Chest Congestion & Cough Relief DM

exchange select

Chest Congestion

& Cough Relief DM

20 Softgels  Ages 12+

Manufactured For Your Military Exchange

By AptaPharma Inc.,

1533 Union Avenue, Pennsauken, NJ 08110

1-877-798-5944

aptapharma.com

res

INGREDIENTS AND APPEARANCE

CHEST CONGESTION AND COUGH RELIEF DM 
dextromethorphan hbr, guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-601
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-601-02	2 in 1 CARTON	01/01/2025
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2025

Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(55301-601)