Cold and Flu Severe by Strategic Sourcing Services LLC SMK - 1163 - 2019-1003
Cold and Flu Severe by
Drug Labeling and Warnings
Cold and Flu Severe by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COLD AND FLU SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
Strategic Sourcing Services LLC
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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SMK - 1163 - 2019-1003
Uses
- for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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.
- 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
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- 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.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
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| children under 12 years |
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Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #2, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
sunmark®
compare to Tylenol® Cold & Flu Severe active ingredients†
NDC: 49348-118-04
cold & flu severe
Headache, fever, sore throat, nasal congestion, cough, chest congestion, clears out mucus
Pain Reliever/Fever Reducer
ACETAMINOPHEN
Nasal Decongestant PHENYLEPHRINE HCL
Cough Suppressant DEXTROMETHORPHAN HBR
Expectorant GUAIFENESIN
COOL TASTE INSTANT COOLING SENSATION
24 CAPLETS
| COLD AND FLU SEVERE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated |
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| Labeler - Strategic Sourcing Services LLC (116956644) |