Otc - Active Ingredient
Drug Facts
Active ingredients (per softgel)
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Chest Congestion And Cough Relief Dm Capsule, Liquid Filled
FDA Label NDC 55301-601
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Army And Air Force Exchange Service for the product Chest Congestion And Cough Relief Dm (NDC 55301-601). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
