Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers Company for the product Sinus Severe (NDC 63941-275). 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
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Expectorant
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.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center 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, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
1-800-426-9391
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Compare to the active ingredients in
Tylenol® Sinus Severe*
Sinus
Severe
ACETAMINOPHEN
GUAI F ENE S IN
PHENYLE PHRINE HCl
PAIN RELIEVER/FEVER REDUCER
EXPECTORANT
NASAL DECONGESTANT
For relief of:
• Sinus headache & pressure
• Nasal congestion
• Mucus
• Chest congestion
DAYTIME
Actual Size
NON-DROWSY
24 CAPLETS
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Tylenol® SINUS SEVERE.
50844 REV0922J52708
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
PROUDLY DISTRIBUTED BY: ASSOCIATED WHOLESALE GROCERS, INC.
KANSAS CITY, KANSAS 66106
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* Please review the disclaimer below.