The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Ultra Concentrated Daytime/ Nighttime Severe Softgel (NDC 51316-547). 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 - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
- minor aches and pains
- headache
- nasal congestion
- sore throat
- sinus congestion and pressure
- cough
Uses
- minor aches and pains
- headache
- nasal congestion
- cough
- sinus congestion and pressure
- runny nose
- sneezing
- sore throat
Warnings
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 or general allergic 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Warnings
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 or general allergic 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.
Do not use
Do not use
Ask a doctor before use if you have
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
When using this product, do not exceed recommended dosage
When using this product
Stop use and ask a doctor if
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
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 (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.
Keep out of reach of children. 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.
Directions
Directions
Other information
store at no greater than 25°C
Other information
Inactive ingredients FD&C yellow no. 6 al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Inactive ingredients D&C yellow no. 10 al. lake, FD&C blue no.1 al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Questions or comments? Call 1-877-290-4008
Questions or comments? Call 1-877-290-4008
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