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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sinus Severe (NDC 70677-1005). 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, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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.
| adults and children 12 years and over |
|
| children under 12 years |
|
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
Call 833-358-6431
NDC 70677-1005-1
COMPARE TO TYLENOL® SINUS SEVERE ACTIVE INGREDIENTS*
Foster & Thrive™
FOR ADULTS
Sinus Severe
Acetaminophen 325 mg,
Phenylephrine HCl 325 mg,
Guaifenesin 200 mg
PAIN RELIEVER/FEVER REDUCER,
NASAL DECONGESTANT,
EXPECTORANT
Day | Non-Drowsy | Cool Taste
For relief of:
• Sinus Headache
• Sinus Pressure
• Nasal Congestion
• Mucus + Chest Congestion
ACTUAL SIZE
24 CAPLETS
* Please review the disclaimer below.