Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Indications and uses
temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever
Dosage and administration
do not use more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Storage and handling
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
minor aches and pains
nasal congestion
headache
sinus congestion and pressure
promotes sinus drainage
temporarily reduces fever
Warnings
WARNINGS SECTION
Liver warning: This product contains acetaminophen. 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.
Do not use
OTC - DO NOT USE SECTION
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 monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
OTC - ASK DOCTOR SECTION
heart disease
thyroid disease
diabetes
liver disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking the blood thinning drug warfarin.
When using this product
OTC - WHEN USING SECTION
do not exceed recommended dosage.
Stop use and ask a doctor if
OTC - STOP USE SECTION
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 symptoms occur
These could be signs of a serious condition.
If pregnant or breast-feeding,
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use.
Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of accidental 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.
Directions
DOSAGE & ADMINISTRATION SECTION
do not use more than directed
adults and children 12 years and over
take 2 caplets every 4 hours
do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor
Other information
STORAGE AND HANDLING SECTION
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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 Kenvue Inc.,
owner of the registered trademark SUDAFED PE® SINUS
PRESSURE + PAIN.
50844 ORG082050208
DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
NOT 100% SATISFIED?
Return within 30 days to the store of purchase
for a refund (with receipt) or exchange.
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