FDA Label for Maximum Strength Nighttime Cold And Flu
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL -
Maximum Strength Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product The Kroger Co. 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) | Purposes |
|---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Diphenhydramine HCl 25 mg | Antihistamine/cough suppressant |
Phenylephrine HCl 10 mg | Nasal decongestant |
Uses
• temporarily relieves these common cold and flu symptoms:• cough• nasal congestion• minor aches and pains• sore throat• headache• runny nose• sneezing
• temporarily reduces fever• controls cough to help you get to sleep
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 6 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
Allergy alert: Acetaminophen may cause severe skin reactions .Symptoms may include:
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
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.• with any other drug containing diphenhydramine, even one used on the skin• 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.
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to an enlarged prostate gland• glaucoma• a breathing problem such as emphysema or chronic bronchitis• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If
• you are taking the blood thinning drug warfarin• taking sedatives or tranquilizers
When Using This Product
• do not use more than directed• excitability may occur, especially in children• marked drowsiness may occur• alcohol, sedatives, and tranquilizers may increase drowsiness• avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
• nervousness, dizziness, or sleeplessness occur• pain, nasal congestion, or cough gets worse or lasts more than 7 days• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
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 older: 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 6 mg• low sodium• store at room temperature• do not refrigerate• dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
1-888-287-1915
Principal Display Panel -
NDC# 30142-736-06
Compare to Mucinex® Fast-Max® Maximum Strength Might Time Cold & Flu Active Ingredients
Maximum Strength
Night TimeCold & Flu
Diphenhydramine HCl Antihistamine/Cough Suppressant
Phenylephrine HCl Nasal Decongestant• Sore Throat; Itchy Throat-Cough• Nasal Congestion – Sneezing & Runny Nose• Headache – Body Pain
For Ages 12+
6 FL OZ (180 mL)
*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast- Max® Maximum Strength Nighttime Cold & Flu
Tamper evident: do not use if printed seal under cap is broken or missing.
‡Maximum Strength per 4 hour dose.
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