Cold and Flu by Chalkboard Health Inc / LNK International, Inc. Fluent 44-011-Delisted
Cold and Flu by
Drug Labeling and Warnings
Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Chalkboard Health Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COLD AND FLU SEVERE NIGHT- acetaminophen, diphenhydramine hcl, phenylephrine hcl solution
Chalkboard Health Inc
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Fluent 44-011-Delisted
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) | |
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