The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Mucus-clear Jr. Nighttime (NDC 68703-326). 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 hpus active ingredients, uses*, warnings, directions, other safety information, inactive ingredients, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HPUS Active Ingredients: Each dose contains equal parts of: Chamomilla 6C, Cina 6C, Kali bic 6C, Kali carb 30C, Kali mur 6C, Pulsatilla 6C.
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*: Homeopathic remedy to reduce mucus, phlegm, throat congestion, and accompanying sleeplessness.
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose treat, cure or prevent any disease.
Warnings: I f symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions: Mix in 1/4 cup water and sip slowly, approximately 15 minutes before bed. Alternatively, drops may be taken directly into the mouth. Babies 6-11 months: 1 drop. Children 1-8: 1 drop per year of age. Children 9-14: Take 0.25 mL. Repeat every 4 hours during the night as needed until symptoms subside.
Contains no artificial flavors or colorants. No gluten added.
Tamper resistant for your protection. Use only if safety seal is intact.
Inactive Ingredients: Purified water, USP grain alcohol (20% by volume).
Keep this and all medication out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Temporarily relieves common cold symptoms & accompanying sleeplessness in children
* Please review the disclaimer below.
