FDA Label for Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- WARNINGS
- DO NOT USE
- OVERDOSE WARNINGS.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS (MAXIMUM STRENGTH COLD, FLU AND SORE THROAT)
- USES (OVERNIGHT COLD & FLU
- IF PREGNANT OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENTS (OVERNIGHT COLD & FLU)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - KIT CARTON
Target Maximum Strength Cold Flu And Sore Throat Overnight Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. 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.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each 20 mL) MAXIMUM STRENGTH‡ COLD, FLU & SORE THROAT | Purposes |
|---|---|
Acetaminophen 650 mg Dextromethorphan HBr 20 mg | Pain reliever/fever reducer Cough suppressant |
Guaifenesin 400 mg Phenylephrine HCl 10 mg | Expectorant Nasal decongestant |
| Active ingredients (in each 20 mL) | Purposes |
|---|---|
| OVERNIGHT COLD & FLU | |
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 20 mg Triprolidine HCl 2.5 mg | Antihistamine/cough suppressant Antihistamine |
Uses
MAXIMUM STRENGTH COLD, FLU & SORE THROAT
▪ temporarily relieves these common cold and flu symptoms:▪ cough▪ nasal congestion▪ minor aches and pains▪ sore throat▪ headache▪ stuffy nose▪ sinus congestion and pressure▪ temporarily reduces fever▪ temporarily promotes nasal and for sinus drainage▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take:
▪ more than6 doses in 24 hours which is the maximum daily amount▪ with other drugs containing acetaminophen▪ 3 or more alcoholic drinks daily while using this product▪ skin reddening▪ blisters▪ rash. if a skin reaction occurs, stop use and seek medical help right away.▪ more than 4000 mg in 24 hours, which is the maximum daily amount▪ with other drugs containing acetaminophen▪ 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Sore throat warnings: 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.
Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take:
Do Not Use
▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Overdose Warnings.
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 at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.
Directions
▪ do not take more than directed (see Overdose warning)▪ do not take more than 6 doses in any 24- hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor▪ mL = milliliter▪ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours▪ children under 12 years of age: Do not use▪ do not take more than directed (see overdose warnings▪ do not take more than 4 doses in any 24-hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor▪ adults and children 12 years of age and over: 20 ml in dosing cup provided every 4 hours▪ children under 12 years of age: do not use
Other Information
▪ each 20 mL contains: sodium 8 mg▪ store at room temperature▪ do not refrigerate▪ each 20 mL contains: sodium 10 mg▪ low sodium▪ store at room temperature▪ do not refrigerate
Inactive Ingredients (Maximum Strength Cold, Flu And Sore Throat)
anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Uses (Overnight Cold & Flu
▪ temporarily relieves these common cold and flu symptoms:▪ cough▪ minor aches and pains▪ sore throat▪ headache▪ runny nose▪ sneezing▪ itching of the nose or throat▪ itchy, watery eyes due to hay fever▪ temporarily reduces fever▪ controls cough to help you get to sleep
If Pregnant Or Breast Feeding
ask a health professional before use
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 Centre right away at 1-800-222-1222.
Quick medical attention is critical for adults as well as for children, even if you do not notice any signs
Inactive Ingredients (Overnight Cold & Flu)
anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose and xanthan gum
Questions Or Comments?
(1-866-467-2748)
Principal Display Panel - Kit Carton
VALUE PACK
NDC 11673-691-12
Compare to Maximum Strength‡ Mucinex® Fast Max® Cold, Flu and Sore Throat Active Ingredients*
Maximum Strength‡
Cold, Flu and Sore Throat
Acetaminophen • Pain Reliever/Fever Reducer
Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant
Phenylephrine HCl • Nasal Decongestant
• Controls Cough, Thins & Loosens Mucus• Nasal & Chest Congestion• Sinus pressure & Congestion• Body Pain, Headache, Fever & Sore Throat• Cough• Fever• Sore Throat• Runny Nose• Sneezing
For Ages 12+
6 FL. OZ. (180 mL)
*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.
Compare to Mucinex® Nightshift Cold, Flu & Sore Throat Active Ingredients**
Overnight Cold & Flu
Acetaminophen • Pain Reliever/Fever Reducer
Dextromethorphan HBr • Cough Suppressant
Triprolidine HCl • Antihistamine
Night Time Relief for a Better Morning
Maximum Strength per 4-hour dose
For Ages 12+
6 FL OZ (180 mL)
**This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu.
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.
See bottle for full labeling
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DO NOT TAKE MAXIMUM STRENGTH COLD, FLU & SORE THROAT & OVERNIGHT COLD & FLU LIQUIDS AT THE SAME TIME.
* Please review the disclaimer below.