ProductAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure18 sections
Indications and uses
temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage
Dosage and administration
take only as directed do not exceed 8 Softgels per 24 hrs Adults & children 12 years & over 2 softgels with water every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use
temporarily restores free breathing through the nose
promotes nasal and/or sinus drainage
Warnings
WARNINGS SECTION
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
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
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.
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
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis, or emphysema
trouble urinating due to enlarged prostate gland
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 use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, & tranquilizers may increase drowsiness
Stop use and ask a doctor if
OTC - STOP USE SECTION
you get nervous, dizzy or sleepless
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
Keep out of reach of children.
Overdosage
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.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
take only as directed
do not exceed 8 Softgels per 24 hrs
Adults & children 12 years & over
2 softgels with water every 4 hours
Children 4 to under 12 years
Ask a doctor
Children under 4 years
Do not use
Other information
OTHER SAFETY INFORMATION
Store at no greater than 25ºC
Inactive ingredients
INACTIVE INGREDIENT SECTION
FD&C Blue No.1, D&C Yellow No.10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol sorbitan solution.
TAMPER EVIDENT
SPL UNCLASSIFIED SECTION
This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.
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