COLD AND FLU SEVERE NIGHT- acetaminophen, diphenhydramine hcl, phenylephrine hcl solution
Chalkboard Health Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Fluent 44-011
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- minor aches and pains
- runny nose and sneezing
- sinus congestion and pressure
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- headache
- cough
- sore throat
- nasal congestion
- temporarily reduces fever
- controls cough to help you get to sleep
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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:
- blisters
- rash
- skin reddening
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.
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 product containing diphenhydramine, even one used on 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- glaucoma
- thyroid disease
- heart disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
- diabetes
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
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 exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other information
-
each 20 mL contains: sodium 9 mg
- use by expiration date on package
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum
Principal display panel
NDC 79395-011-45
Fluent™
Cold+Flu
Severe NIGHT
Acetaminophen
Diphenhydramine HCl
Phenylephrine HCl
Pain Reliever/Fever Reducer
Antihistamine/
Cough Suppressant
Nasal Decongestant
Maximum Strength
BERRY
FLAVOR
6 FL OZ (177 mL)
F-011-45 ORG
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed By:
Chalkboard Health, Inc.
Princeton, NJ 08540
getfluenthealth.com
50844 ORG082001145
Fluent 44-011
| COLD AND FLU
SEVERE NIGHT
acetaminophen, diphenhydramine hcl, phenylephrine hcl solution |
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| Labeler - Chalkboard Health Inc (117569507) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | manufacture(79395-011) , pack(79395-011) | |