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Cold + Flu Severe Day
Drug Facts
Cold + Flu Severe Night
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc for the product Cold And Flu Severe Day And Night (NDC 83324-092). 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.
Cold + Flu Severe Day
Drug Facts
Cold + Flu Severe Night
Drug Facts
| Active ingredients (in each Day caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each Night caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Chlorpheniramine Maleate 2 mg | Antihistamine |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| 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
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.
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 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.
taking the blood thinning drug warfarin
do not exceed recommended dosage
These could be signs of a serious condition.
These could be signs of a serious condition.
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.
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.
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 |
|
| adults and children 12 years and over |
|
| children under 12 years |
|
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
QUALITY CHOICE®
NDC 83324-092-24
†Compare to Active Ingredients in TYLENOL® Cold + Flu Severe Day and Night
Cold + Flu Severe Day + Night For Adults
DAY
Actaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever | Fever Reducer,
Cough Suppressant,
Nasal Decongestant,
Expectorant
For Relief of:
Head + Body Aches
Fever + Sore Throat
Cough
Nasal Congestion
Mucus + Chest Congestion
16 DAY CAPLETS
NIGHT
Actaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Pain Reliever | Fever Reducer,
Antihistamine,
Cough Suppressant,
Nasal Decongestant,
For Relief of:
Head+ Body Aches
Fever + Sore Throat
Cough
Nasal Congestion
Runny Nose
8 NIGHT CAPLETS
Actual Size
24 COOL TASTE CAPLETS
* Please review the disclaimer below.