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 nameGUAIFENESIN
Labeler / manufacturerRaritan Pharmaceuticals Inc
RouteORAL
Drug classExpectorant
Product NDC68163-743
Label effective date2026-09-09
Official product label reference
DRx Choice Fruit Punch — Raritan Pharmaceuticals Inc
This page contains 12 source sections for GUAIFENESIN, oral route. Label set a19d7e1c-c04e-41c6-8af6-ecde96299216, version 8.
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
Use helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Purpose
Purpose 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 • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 – 20 mL every 4 hours children under 12 years do not use
Table text from source:
| age | dose
| adults and children 12 years and over | 10 – 20 mL every 4 hours
| children under 12 years | do not use
Warnings
Warnings 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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).
Active ingredient
Active ingredient (in each 10 mL) Guaifenesin, USP 200 mg
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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 10 mL contains: sodium 4 mg • store at room temperature
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.