COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
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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Active ingredients (in each liquid-filled capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- nasal congestion
- headache
- fever
- minor aches and pains
- cough due to minor throat and bronchial irritation
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:
- skin reddening
- blisters
- rash
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
- 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- heart disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
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 rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- do not take more than 8 capsules per 24 hours
- adults and children 12 years and over: take 2 capsules with water every 4 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)
- protect from light, heat and moisture
- see end flap for expiration date and lot number
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink
Questions or comments?
1-800-426-9391
Principal Display Panel
NDC 79395-730-08
ºFluent™
Multi-Symptom
Cold DAY
Acetaminophen
Dextromethorphan HBr
Phenylephrine HCI
Pain Reliever/Fever Reducer
Cough Suppressant
Nasal Decongestant
24 Liquid-Filled Capsules/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
Product of Dubai
Packaged and Quality
Assured in the USA
50844 ORG012073008
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org