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Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Daytime Cold And Flu Mini Softgels (NDC 83059-0072). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each softgel), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
temporarily relieves common cold/flu symptoms:
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
Allergy Alert:Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product
• do not use more than directed.
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
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
| adults & children 12 yrs & over | 2 Softgels with water every 4 hrs |
| hildren 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
• store between 20-25°C (68-77°F).
Avoid high humidity and excessive heat.
Protect from light.
1-800-373-6981
anhydrous citric acid, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, mica, N-butyl alcohol, polyethylene glycol-400, propylene glycol, povidone (PVP K30), purified water, shellac, sorbitol solution, titanium dioxide
Daytime Cold & Flu minin Softgels
Multi-Symptom Relief
Carton
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