ELN - 1178 - 2019-1001
Drug Labeling and Warnings
Drug Details [pdf]
DAYTIME SEVERE COLD AND FLU RELIEF MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
Supervalu Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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ELN - 1178 - 2019-1001
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion and pressure
- cough due to minor throat & bronchial irritation
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
- 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- 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.
Directions
- take only as directed (see overdose warning)
- do not exceed 4 doses per 24 hours
| adults and children 12 years and over | take 2 caplets every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
Equaline®
compare to Vicks® DayQuil® Severe Cold & Flu active ingredients†
NDC: 41163-510-02
maximum strength, non-drowsy
daytime severe
cold & flu relief
acetaminophen (pain reliever/fever reducer)
phenylephrine HCl (nasal decongestant)
dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
relieves:
headache, fever, sore throat, minor aches & pains
nasal/sinus congestion & sinus pressure
cough
chest congestion
12 caplets
| DAYTIME SEVERE COLD AND FLU RELIEF
MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated |
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| Labeler - Supervalu Inc. (006961411) |
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