Otc - Active Ingredient
Active ingredient - (per tablet)
Dextromethorphan Hydrobromide 20mg Cough Suppressant
Guaifenesin 400mg Expectorant
Cvs Chest Congestion Relief
FDA Label NDC 10956-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reese Pharmaceutical Co for the product Cvs Chest Congestion Relief (NDC 10956-003). 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 - ask doctor, otc - stop use, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
Ask doctor before use if you have
persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
cough is accompanied by excessive phlegm (mucous)
Otc - Stop Use
Stop use and ask doctor if
Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition
Otc - Do Not Use
Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children, In ase of overdose, get medical help or contact a Poison Center immediately
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Inactive Ingredient
magnesium stearate, microcrystalline cellulose,
colloidal silicon dioxide, (co) povidone, dicalcium
phosphate, maltodextrin, sodium starch glycolate, stearic acid
Dosage & Administration
Directions
• Adults and children 12 years of age and over:
take 1 tablet every 4 hours as needed
• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other information store at 15'- 30' C (59'- 86'F) Rev 10/U9 RCCF
Indications & Usage
Uses. temporarily relieves cough due to minor throat and bronchial irritation
as may occur with a common cold • helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make coughs more productive
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Warnings
Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.Package Label.Principal Display Panel
Package Label (Cvsrccvsv1)
* Please review the disclaimer below.
