ProductSevere Cough and Congestion and Cold and Flu Daytime, Nighttime
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections
Indications and uses
temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants nasal congestion due to a cold the intensity of coughing the impulse to cough to help you get to sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and administration
do not use more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use
Storage and handling
each caplet contains: sodium 3 mg (Daytime only) TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
nasal congestion due to a cold
the intensity of coughing
the impulse to cough to help you get to sleep
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Uses (Nighttime only)
INDICATIONS & USAGE SECTION
temporarily relieves these common cold and flu symptoms:
headache
sore throat
nasal congestion
runny nose and sneezing
cough
minor aches and pains
temporarily reduces fever
controls cough to help you get to sleep
Warnings
WARNINGS SECTION
Liver warning (Nighttime only): This product contains acetaminophen. Severe liver damage may occur if you take
with other drugs containing acetaminophen
more than 4,000 mg of acetaminophen in 24 hours
3 or more alcoholic drinks every day while using this product
Allergy alert (Nighttime only): Acetaminophen may cause severe skin reactions. Symptoms may include:
blisters
rash
skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning (Nighttime only): 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 product containing diphenhydramine, even one used on skin (Nighttime 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 this product.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
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
diabetes
thyroid disease
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
high blood pressure
difficulty in urination due to enlargement of the prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
glaucoma (Nighttime only)
liver disease (Nighttime only)
Ask a doctor or pharmacist before use if you are (Nighttime only)
OTC - ASK DOCTOR/PHARMACIST SECTION
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
When using this product
OTC - WHEN USING SECTION
do not exceed recommended dosage
marked drowsiness may occur (Nighttime only)
excitability may occur, especially in children (Nighttime only)
alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
use caution when driving a motor vehicle or operating machinery (Nighttime only)
avoid alcoholic beverages (Nighttime only)
Stop use and ask a doctor if
OTC - STOP USE SECTION
nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or occur with fever (Daytime only)
redness or swelling is present (Nighttime only)
pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
new symptoms occur (Nighttime only)
fever gets worse or lasts more than 3 days (Nighttime only)
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
In case of 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.
Do not take DAYTIME and NIGHTTIME products at the same time.
Directions
DOSAGE & ADMINISTRATION SECTION
do not use more than directed
do not take more than 12 caplets in any 24-hour period
adults and children 12 years and over: take 2 caplets every 4 hours
children under 12 years: do not use
Other information
STORAGE AND HANDLING SECTION
each caplet contains: sodium 3 mg (Daytime only)
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package
Inactive ingredients (Daytime only)
INACTIVE INGREDIENT SECTION
corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Inactive ingredients (Nighttime only)
INACTIVE INGREDIENT SECTION
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide
Questions or comments?
OTC - QUESTIONS SECTION
1-800-426-9391
Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
COMBO PACK 30 CAPLETS TOTAL
NDC 41250-848-95
Meijer®
Maximum Strength Daytime Severe
Congestion & Cough
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