FDA Label for Maximum Strength Nighttime Cold And Flu
View Indications, Usage & Precautions
Maximum Strength Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Target Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
- Acetaminophen 325 mg
- Dextromethorphan HBr 10 mg
- Doxylamine succinate 6.25 mg
- Phenylephrine HCl 5 mg
Inactive Ingredient
FD&C Blue No. 1, gelatin, glycerin,polyethylene glycol , povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution titanium dioxide,
Otc - Purpose
Purpose
- Pain reliever/Fever reducer
- Cough suppressant
- Antihistamine
- Nasal decongestant
Indications & Usage
- temporarily relieves common cold/flu symptoms:
- temporarily reduces fever
- controls cough to help you get to sleet
nasal congestion, cough, nasal congestion, minor aches and pains, sore throat, headache, runny nose and sneezing
Dosage & Administration
Directions -Do not take more than directed (see Overdose warning)
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Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- Skin reddening
- Blisters
- Rash
Allergy Alert:
acetaminophen may cause severe skin reactions. Symptoms may include:
Sore troat 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. 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.
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