Hy-Vee, Inc. Severe Cold & Flu Drug Facts
Severe Cold and Flu by
Drug Labeling and Warnings
Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by HyVee Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
HyVee 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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Hy-Vee, Inc. Severe Cold & Flu Drug Facts
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion and pressure
- cough due to minor throat and 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
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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
- 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
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- 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 5 days (children) or 7 days (adults)
- 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.
Keep out of reach of children.
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
- take only as directed – see Overdose warning
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
|
adults & children 12 yrs & over |
30 mL every 4 hrs |
|
children 6 to under 12 yrs |
15 mL every 4 hrs |
|
children 4 to under 6 yrs |
ask a doctor |
|
children under 4 yrs |
do not use |
Inactive ingredients
butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Package/Label Principal Display Panel
COMPARE TO the Active Ingredients of Vicks® DayQuil® Severe Cold & Flu
See New Warnings
Maximum Strength
Severe Cold & Flu
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
Daytime
Non-Drowsy
Headache, Fever, Sore Throat, Minor Aches & Pains
Nasal/Sinus Congestion & Sinus Pressure
Cough – Chest Congestion
Antihistamine Free
ALCOHOL FREE
8 FL OZ (237 mL)
| SEVERE COLD AND FLU
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution |
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| Labeler - HyVee Inc (006925671) |