Drugplain

Sinus and Headache 325 mg/1

ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE · TABLET, COATED · HYVEE INC

No Recall HistoryCurrently in Shortage
Plain English

Sinus and Headache is a tablet, coated containing acetaminophen and phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by HYVEE INC.

Key Facts

Brand Name
Sinus and Headache
Generic Name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
42507-223
Manufacturer
HYVEE INC
Strength
325 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
10/22/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain12 reports
cholecystitis chronic9 reports
injury7 reports
pulmonary embolism7 reports
abdominal pain upper6 reports
gallbladder disorder6 reports
abdominal pain5 reports
anxiety5 reports
chest pain5 reports
cholelithiasis5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used swallow whole; do not crush or chew drink a full glass of water with each dose adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours children under 12 years: do not use

Warnings

Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Frequently Asked Questions

What is Sinus and Headache used for?

Sinus and Headache contains ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Sinus and Headache a controlled substance?

Sinus and Headache is not classified as a controlled substance by the DEA.

What is the generic name for Sinus and Headache?

The generic name for Sinus and Headache is ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE. There are 11 other brand versions of ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE.

What is the NDC code for Sinus and Headache 325 mg/1?

The NDC (National Drug Code) for Sinus and Headache 325 mg/1 is 42507-223, listed by HYVEE INC.

Product NDC

42507-223

Package NDC

42507-223-05

Other Sinus and Headache Dosages

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)