Otc - Active Ingredient
Active ingredients
(in each 30 mL (2 TBSP))
Choline Salicylate (NSAID)* 870 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co for the product Kroger Sinus Pain And Pressure (NDC 30142-774). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
(in each 30 mL (2 TBSP))
Choline Salicylate (NSAID)* 870 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever / fever reducer
Expectorant
Nasal decongestant
Uses
Temporarily relieves nasal congestion due to common cold, hay fever and other upper respiratory allergies:
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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
Ask a doctor before use if
When using this product do not use more than directed
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAID) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
edetate disodium, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol
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