Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections
Indications and uses
• temporarily relieves these common cold and flu symptoms: • cough • minor aches and pains • headache • nasal congestion • sore throat • sinus congestion and pressure • runny nose (NIGHT TIME only) • sneezing (NIGHT TIME only) • itching of the nose or throat (NIGHT TIME only) • itchy, watery eyes due to hay fever (NIGHT TIME only) • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial pas...
Dosage and administration
• do not take more than directed (see Overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years of age and over: take 2 caplets every 4 hours • children under 12 years of age: do not use
Storage and handling
• each caplet contains: sodium 4 mg (DAY TIME COLD & FLU only) • store at 20-25 ° C (68-77 ° F)
Active ingredients (in each caplet) DAY TIME COLD & FLU
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purposes - Day Time
OTC - PURPOSE SECTION
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Active ingredients (in each caplet) NIGHT TIME COLD & FLU
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Purposes - Night Time
OTC - PURPOSE SECTION
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Uses
INDICATIONS & USAGE SECTION
temporarily relieves these common cold and flu symptoms:
cough
minor aches and pains
headache
nasal congestion
sore throat
sinus congestion and pressure
runny nose (NIGHT TIME only)
sneezing (NIGHT TIME only)
itching of the nose or throat (NIGHT TIME only)
itchy, watery eyes due to hay fever (NIGHT TIME only)
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
controls cough to help you get to sleep
temporarily reduces fever
Warnings
WARNINGS SECTION
Liver warning: These products contain 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 these products
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
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 skin (NIGHT TIME only)
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 these products.
if you have ever had an allergic reaction to these products or any of their ingredients
Ask a doctor before use if you have
OTC - ASK DOCTOR SECTION
liver disease
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
glaucoma (NIGHT TIME only)
a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking the blood thinning drug warfarin
taking sedatives or tranquilizers (NIGHT TIME only)
When using these products
OTC - WHEN USING SECTION
do not use more than directed
excitability may occur, especially in children (NIGHT TIME only)
marked drowsiness may occur (NIGHT TIME only)
alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
avoid alcoholic drinks (NIGHT TIME only)
be careful when driving a motor vehicle or operating machinery (NIGHT TIME 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 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
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.
Directions
DOSAGE & ADMINISTRATION SECTION
do not take more than directed (see Overdose warning)
do not take more than 10 caplets in any 24-hour period
adults and children 12 years of age and over: take 2 caplets every 4 hours
children under 12 years of age: do not use
Other information
STORAGE AND HANDLING SECTION
each caplet contains: sodium 4 mg (DAY TIME COLD & FLU only)
store at 20-25°C (68-77°F)
Inactive ingredients (DAY TIME COLD & FLU)
INACTIVE INGREDIENT SECTION
croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Inactive ingredients (NIGHT TIME COLD & FLU)
INACTIVE INGREDIENT SECTION
crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Questions or comments?
OTC - QUESTIONS SECTION
1-800-719-9260
Package/Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Compare to the active ingredients in Mucinex® Fast-Max® Day Time & Night Time
MAXIMUM STRENGTH
Daytime
Severe Cold
Acetaminophen
Pain reliever, Fever reducer
Dextromethorphan HBr
Cough suppressant
Guaifenesin – Expectorant
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Controls cough
Thins & loosens mucus
Relieves nasal & chest congestion
Relieves aches, fever & sore throat
FOR AGES 12+
Actual Size
MAXIMUM STRENGTH
Nighttime
Severe Cold
Acetaminophen
Pain reliever, Fever reducer
Diphenhydramine HCl
Antihistamine, Cough Suppressant
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Controls cough
Relieves runny nose & sneezing
Relieves nasal congestion
Relieves aches, fever & sore throat
FOR AGES 12+
Actual Size
20 DAYTIME CAPLETS & 10 NIGHTTIME CAPLETS
TOTAL 30 CAPLETS
daytime severe cold nighttime severe cold image 1daytime nightime severe cold image 2
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