Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Sinus And Headache (NDC 50844-467). 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 active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Nasal decongestant
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.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
1-800-426-9391
Quality
+Plus
NDC 50844-467-08
*Compare to active ingredients in Tylenol® SINUS + HEADACHE
DAYTIME
Sinus & Headache
Acetaminophen
Phenylephrine HCl
PAIN RELIEVER / FEVER REDUCER
NASAL DECONGESTANT
•Sinus Headache • Sinus Pressure
•Nasal Congestion • Pseudoephedrine Free
24 Caplets NON-DROWSY
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® SINUS + HEADACHE.
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
50844 ORG031646608
* Please review the disclaimer below.