Otc - Active Ingredient
Active ingredients (in each tablet)
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product First Aid Direct Headache And Congestion Sinus Relief (NDC 42961-126). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each tablet)
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Nasal decongestant
Uses
temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
Ask a doctor before use if you have
Ask a doctor before use if you are taking the blood thining drug warfarin.
Stop use and ask doctor if
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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Other information
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
Questions?
Call 1-800-327-2704 M-F 8AM-5PM
HEADACHE & CONGESTION
SINUS RELIEF
Active Ingredients:
Acetaminophen • Phenylephrine HCl
Pain Reliever/Fever Reducer & Nasal Decongestant
50 Tablets • 25 Packets (2 Tablets in each packet) per Box
* Please review the disclaimer below.