Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDEXTROMETHORPHAN HBR AND GUAIFENESIN
Labeler / manufacturerRARITAN PHARMACEUTICALS
RouteORAL
Drug classExpectorant
Product NDC68163-747
Label effective date2026-09-09
Official product label reference
DRx Choice Children daytime Cough and Chest Congestion — RARITAN PHARMACEUTICALS
This page contains 14 source sections for DEXTROMETHORPHAN HBR AND GUAIFENESIN, oral route. Label set 25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9, version 4.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
Purpose
Purposes Cough suppressant Expectorant
Dosage and administration — label text
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
Table text from source:
| 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
Warnings
Warnings
Active ingredient
Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg
Do not use
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
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
When to stop use and seek help
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.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
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.
Storage and handling
Other information ▪ each 20 ml contains: sodium 10 mg ▪ store at room temperature. Do not refrigerate.
Table text from source:
| 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
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.