Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Severe Allergy Plus Sinus Headache (NDC 49035-543). 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
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg
Pain reliever
Antihistamine
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.
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, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin
1-888-287-1915
equate™
NDC 49035-543-09
Compare to Benadryl® Severe Allergy Plus Sinus Headache Active Ingredients*
Maximum Strength
Severe Allergy **
Plus Sinus Headache
Acetaminophen, Diphenhydramine HCl,
Phenylephrine HCl
Pain Reliever/Antihistamine/Nasal Decongestant
Relieves:
• Sinus headache
• Sinus congestion
• Sinus pressure
• Sneezing
• Runny nose
• Itchy throat
• Itchy, watery eyes
20
CAPLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY:
Wal-Mart Stores, Inc.,
Bentonville, AR 72716
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Severe Allergy Plus Sinus Headache.
50844 REV0516F54309
Satisfaction guaranteed- or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect please call 1-888-287-1915.
* Please review the disclaimer below.