Drugplain

CVS 100 mg/5mL

Childrens Stuffy Nose and Cold · SOLUTION · CVS PHARMACY, INC

10 Recalls on Record
Plain English

CVS Children's Stuffy Nose and Cold is an over-the-counter liquid medication containing guaifenesin, an expectorant that helps thin mucus to make coughs more productive. It is used to help relieve chest congestion and nasal stuffiness associated with colds in children.

Key Facts

Brand Name
CVS
Generic Name
Childrens Stuffy Nose and Cold
NDC Code (Product)
69842-487
Manufacturer
CVS PHARMACY, INC
Strength
100 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
03/01/2022

Recall History

10 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class III01/07/2020

Sigan Industries Inc.

Microbial contamination of non-sterile product.

TerminatedVoluntary: Firm initiated
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II06/05/2019

Sun Pharmaceutical Industries, Inc.

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

TerminatedVoluntary: Firm initiated
Class II01/08/2016

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue74,829 reports
drug ineffective70,476 reports
nausea66,391 reports
off label use61,750 reports
dyspnoea58,734 reports
pain56,781 reports
diarrhoea55,762 reports
headache53,521 reports
vomiting45,630 reports
dizziness45,480 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves: runny nose sneezing itchy, watery eyes due to hay fever itching of the nose or throat

Dosage & Administration

Directions do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product ml = milliliter age Dose adults and children 12 years and over 20 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours children under 6 years do not use

Warnings

Warnings Do not use to sedate a child or to make a child sleepy Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, or chronic bronchitis. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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 at 1-800-222-1222.

Frequently Asked Questions

What is CVS used for?

CVS Children's Stuffy Nose and Cold is an over-the-counter liquid medication containing guaifenesin, an expectorant that helps thin mucus to make coughs more productive. It is used to help relieve chest congestion and nasal stuffiness associated with colds in children.

Is CVS a controlled substance?

CVS is not classified as a controlled substance by the DEA.

What is the generic name for CVS?

The generic name for CVS is Childrens Stuffy Nose and Cold. There are 1 other brand versions of Childrens Stuffy Nose and Cold.

What is the NDC code for CVS 100 mg/5mL?

The NDC (National Drug Code) for CVS 100 mg/5mL is 69842-487, listed by CVS PHARMACY, INC.

Product NDC

69842-487

Package NDC

69842-487-04

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)