Daytime Non-Drowsy COLD/FLU
Daytime Non-Drowsy COLD/FLU is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE manufactured by Salado Sales, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231229.
- Generic name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- Salado Sales, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 57243-506
- Application
- M013
- Label effective
- 20231229
Active ingredients
Indications & Usage
Uses temporarily relieves these common cold/flu symptoms: minor aches and pains ● headache ● sore throat ● fever nasal congestion ● cough due to minor throat and bronchial irritation
Dosage & Administration
Directions ● take only as recommended (see overdose warning) use dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours age dose adults and children 12 years and over 30 mL (2 TBSP) every 4 hours children 6 years to under 12 years 15 mL (1 TBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
Contraindications
Not available.
Warnings
Warnings Liver Warning: The product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 4doses (30 mL each) in 24 hours, which is the maximum daily amount for this product ■ child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using the product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Adverse Reactions
Not available.