FDA Label for Chest Congestion And Cough Relief Dm

View Indications, Usage & Precautions

Chest Congestion And Cough Relief Dm Product Label

The following document was submitted to the FDA by the labeler of this product Army And Air Force Exchange Service. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Drug Facts

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


Otc - 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.


Otc - 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


Otc - 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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - 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


Otc - 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


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