Drug Facts
Active ingredients (in each 5 mL)
Guaifenesin, USP 100 mg
Phenylephrine HCl, USP 2.5 mg
Drx Choice Childrens Stuffy Nose And Chest Congestion Solution
FDA Label NDC 68163-748
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals for the product Drx Choice Childrens Stuffy Nose And Chest Congestion (NDC 68163-748). 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 drug facts, purposes, uses, warnings, ask a doctor before use if the child has, when using this product, stop use and ask a doctor if, 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
Purposes
Expectorant
Nasal Decongestant
Uses
▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive▪ temporarily relieves:▪ nasal congestion due to a cold▪ stuffy nose
Warnings
Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask A Doctor Before Use If The Child Has
▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ cough that occurs with too much phlegm (mucus)▪ persistent or chronic cough such as occurs with asthma
When Using This Product
Stop Use And Ask A Doctor If
▪ nervousness, dizziness or sleeplessness occur▪ symptoms do not get better within 7 days or occur with fever▪ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious illness.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.
Directions
▪ do not give more than 6 doses in any 24 hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor
Age | Dose |
Children 6 years to under 12 years | 10 mL every 4 hours |
Children 4 years to under 6 years | 5 mL every 4 hours |
Children under 4 years | do not use |
Other Information
▪ each 5 mL contains: sodium 3 mg▪ very low sodium▪ store at room temperature▪ do not refrigerate▪ dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum.
Questions Or Comments?
1-866-467-2748
Package Label-Principal Display Panel 4 Fl Oz (118 Ml Bottle)
*Compare to the active ingredients in Children’s Mucinex® Stuffy Nose & Chest Congestion
NDC 68163-748-04
DRx Choice®
Children's
Stuffy Nose & Chest Congestion
Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)
Relieves: Stuffy Nose, Chest congestion, Breaks Up Mucus
Dosage Cup Included
Mixed Berry Flavor
Naturally & artificially flavored
For Ages 4 & Over
4 FL OZ (118 mL)
TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING |
IMPORTANT: Keep this carton for future reference on full labeling. |
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court. East Brunswick
NJ 08816
Drx Choice Children's Stuffy Nose And Chest Congestion (Stuffynose Fig1)
* Please review the disclaimer below.
