Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections
Indications and uses
temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever
Dosage and administration
do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor TBSP = Tablespoon, mL = milliliter Age Dose adults and children 12 years of age and over 30 mL (2 TBSP) children under 12 years of age do not use Attention: use only enclosed ...
Storage and handling
each 30 mL contains: potassium 9 mg, sodium 15 mg Store at 20-25 o C (68-77 o F) TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing
temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
runny nose
sneezing
itchy nose or throat
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
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 daily 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Do not use
OTC - DO NOT USE SECTION
in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on the skin
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.
Ask a doctor before use if you have
OTC - ASK DOCTOR SECTION
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking sedatives or tranquilizers
taking the blood thinning drug warfarin
When using this product
OTC - WHEN USING SECTION
do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
Stop use and ask a doctor if
OTC - STOP USE SECTION
nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep this and all drugs out of the reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick 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
measure the dose correctly using the enclosed dosing cup
take every 4 hours in dosing cup provided, while symptoms persist
do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor
TBSP = Tablespoon, mL = milliliter
Age
Dose
adults and children 12 years of age and over
30 mL (2 TBSP)
children under 12 years of age
do not use
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
STORAGE AND HANDLING SECTION
each 30 mL contains: potassium 9 mg, sodium 15 mg
Store at 20-25oC (68-77oF)
TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing
Inactive ingredients
INACTIVE INGREDIENT SECTION
acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue no.1, FD&C Red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate Questions or comments? 1-855-274-4122
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® ExpressMax™ Nighttime Severe Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: Fred's, Inc. 4300 NEW GETWELL RD MEMPHIS, TN38118 www.fredsinc.com
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
freds Pharmacy
NDC 55315-004-33 Nighttime SEVERE COLD & COUGH Maximum Strength Per 4 Hour Dose
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