Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Severe Cold And Flu Daytime (NDC 41226-780). 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 active ingredients (in each 30 ml), purpose, uses, 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.
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
•skin reddening
•blisters
•rash
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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 as well as for children even if you do not notice any signs or symptoms.
Do not use
Ask a doctor before use if you have
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
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 as well as for children even if you do not notice any signs or symptoms.
Directions
adults & children 12 yrs & over - 30 mL every 4 hrs
children 4 to under 12 yrs - ask a doctor
children under 4 yrs - do not use
Other information
Inactive ingredients citric acid monohydrate, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
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