Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
Directions (Nighttime only) do not take more than directed (see overdose warning) adults and children 12 years and older: take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours C hildren under 12 years: ask a doctor Directions (Daytime only) do not take more than directed (see Warnings) Adults and children 12 years and over: take 2 caplets every 4 h...
Active Ingredients (in each caplet) (Daytime only)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Purpose
OTC - PURPOSE SECTION
NIGHTTIME ONLY
Pain reliever/fever reducer
Cough suppressant
Antihistamine
DAYTIME ONLY
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Use(s)
INDICATIONS & USAGE SECTION
for the temporary relief of the following cold/flu symptoms
minor aches and pains
headache
sore throat
nasal congestion
cough
sinus congestion and pressure
temporarily reduces fever
sneezing and runny nose
helps clear nasal passages
relieves cough to help you sleep (Nighttime only)
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs
more productive (Daytime only)
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
The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. (Nighttime only)
Severe liver damage may occur if you take:
more than 12 caplets in 24 hours, which is the maximum daily amount (Daytime only)
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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 (Nighttime only)
Ask a doctor before use if
OTC - ASK DOCTOR SECTION
you have have
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if
OTC - ASK DOCTOR/PHARMACIST SECTION
you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Nighttime only)
When using this product
OTC - WHEN USING SECTION
do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery (Nighttime only)
Stop use and ask a doctor if
OTC - STOP USE SECTION
nervousness, dizziness, or sleeplessness occur
pain, nasal congestion or cough 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
cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
If pregnant or breastfeeding,
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
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. Taking more than the recommended dose
(overdose) may cause liver damage.
Directions
DOSAGE & ADMINISTRATION SECTION
Directions (Nighttime only)
do not take more than directed (see overdose warning)
adults and children 12 years and older: 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
Directions (Daytime only)
do not take more than directed (see Warnings)
Adults and children 12 years and over: take 2 caplets every 4 hours
do not take more than 12 caplets in 24 hours
Children under 12 years: do not use this adult product in children under 12 years of age.
This will provide more than the recommended dose (overdose) and
may cause liver damage
Other information
SPL UNCLASSIFIED SECTION
store at room temperature 20°– 25°C (68°– 77°F
do not use if blister unit is torn or open
Retain carton for complete drug information.
Inactive ingredients
INACTIVE INGREDIENT SECTION
Inactive ingredients (Nighttime only)
corn starch, crospovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose,
magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch,
polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide May contain: FD&C lake black
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