Head Congestion by Chalkboard Health Inc / LNK International, Inc. Fluent 44-527C-Delisted
Head Congestion by
Drug Labeling and Warnings
Head Congestion 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]
HEAD CONGESTION- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
Chalkboard Health Inc
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Fluent 44-527C-Delisted
Uses
- for the temporary relief of the following cold symptoms:
- headache
- nasal congestion
- minor aches and pains
- sore throat
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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.
- 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
- liver disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- heart disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- thyroid disease
Stop use and ask a doctor if
- redness or swelling is present
- 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
- new symptoms occur
- 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
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal display panel
ºFluent™
NDC: 79395-527-08
Head
Congestion
Acetaminophen
Guaifenesin
Phenylephrine HCl
Pain Reliever/Fever Reducer
Expectorant
Nasal Decongestant
24 Caplets/Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Distributed By:
Chalkboard Health, Inc.
Princeton, NJ 08540
getfluenthealth.com
50844 ORG041852708
Fluent 44-527C ORG0418
| HEAD CONGESTION
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated |
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| Labeler - Chalkboard Health Inc (117569507) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | manufacture(79395-527) , pack(79395-527) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(79395-527) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 117025878 | manufacture(79395-527) | |
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