Sinus and Headache

Generic name: ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE

AAA Pharmaceutical, Inc.

Dosage Form

N/A

Manufacturer

AAA Pharmaceutical, Inc.

Active ingredients

ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE5 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- headache
- sinus congestion and pressure
- nasal congestion
- minor aches and pains
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages
temporarily reduces fever

When using this product do not exceed recommended dosage

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

57344-923-05

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Sign up for full access

Create a free account to view complete drug information, save medications, and more.

Full drug information and details

Save medications to your personal list

Track your medication history

Get personalized drug safety alerts

Create Free Account Sign In

Free forever · No credit card required

adults and children 12 years and over	take 2 caplets every 4 hours swallow whole; do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours
children under 12 years	ask a doctor

Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours childre…

Do not use if…Keep out of reach of children.

Ask a doctor before use if…Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symp…

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and talk to a doctor if…Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoa…

Storage and handlingstore between 20-25°C (68-77°F) in a dry place retain carton for complete product information and warnings

Package labelRESTORE U NDC 57344-923-05 DAYTIME NON-DROWSY †COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® SINUS + HEADACHE FOR ADULTS Sinus + Headache Acetaminophen, Phenylephrine HCl Pain Reliever/Fever Reducer, Nasal Decongestant F…