Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Drx Choice Children Daytime Liquid
FDA Label NDC 68163-747
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 Children Daytime (NDC 68163-747). 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 active ingredients (in each 20 ml), purposes, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Cough suppressant
Expectorant
Uses
▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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 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 taking this product.
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
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.
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.
Directions
▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing cup provided▪ keep dosing cup with product▪ mL = milliliter
Age | Dose |
children under 4 years | do not use |
children 4 to under 6 years | 5 mL every 4 hours |
children 6 to under 12 years | 10 mL every 4 hours |
adults and children 12 years and older | 20 mL every 4 hours |
Other Information
▪ each 20 ml contains: sodium 10 mg▪ store at room temperature. Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, 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 Robitussin® Cough & Chest Congestion DM*
NDC 68163-747-04
DRx Choice®
Children's daytimecough& chestcongestion
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Relieves: Chest congestion, mucus & cough
Sugar Free
Dye Free
No Added Alcohol
For Ages 4 & Over
Grape Flavor
Naturally & Artificially Flavored
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 |
*This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin® Cough & Chest Congestion DM.
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick,
NJ, 08816
Drx Choice Children's Daytime Cough & Chest Congestion (Children Cough Chest Fig1)
* Please review the disclaimer below.
