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Drug Facts
Packaged and distributed by Select Corporation with the permission of GSK Consumer Healthcare
Warren, NJ 07059
The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Theraflu Daytime Severe Cold And Cough (NDC 52904-896). 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, otc - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Packaged and distributed by Select Corporation with the permission of GSK Consumer Healthcare
Warren, NJ 07059
| Active ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if you take
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
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 right away.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Age | Dose |
|---|---|
| adults and children 12 years of age and over | one packet |
| children under 12 years of age | do not use |
acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate
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THERAFLU
SEVERE
COLD & COUGH
DAYTIME
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
BERRY INFUSED
WITH MENTHOL &
GREEN TEA FLAVORS
20 PACKETS
* Please review the disclaimer below.