COMTREX Maximum Strength Day / Night Severe Cold and Sinus
Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-2083
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.
Drug Facts
Active ingredient
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg*
Phenylephrine HCl 5 mg
* antihistamine in nighttime dose only
Purpose
Pain reliever / fever reducer
Antihistamine*
Nasal decongestant
Uses
-
daytime (orange caplets) - temporarily relieves:
- minor aches and pains
- headaches
- nasal congestion
- sinus congestion & pressure
-
nighttime (green caplets) - provides the same relief as the daytime caplets plus temporarily relieves:
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets (8 daytime & 4 nighttime total) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Sore throat warnings: 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
- in a child under 4 years of age
- if you are allergic to acetaminophen
- 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- glaucoma
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostrate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
-
do not exceed recommended dosage
- when using nighttime product:
- drowsiness may occur
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be carful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- new symptoms occur
- you get nervous, dizzy, or sleepless
- redness or swelling is present
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
If pregnant or breast-feeding
ask a health care professional before use.
Keep out of reach of children
In case of 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 use more than directed
-
daytime - orange caplets - take every 4 hours, while symptoms persist
- do not take more than 8 daytime caplets in 24 hours, unless directed by a doctor
-
nighttime - green caplets - take no sooner than 4 hours after the last daytime dose
- wait at least 4 hours before taking an additional nighttime dose, if needed
- do not take more than 4 nighttime caplets in 24 hours, unless directed by a doctor
| Age | Dose |
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and over | 2 caplets |
Other information
- store at controlled room temperature 20-25° C (68-77° F)
Inactive ingredients
-
daytime caplet - benzoic acid, carnauba wax, D&C yellow #10 lake, FD&C red #40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide.
-
nighttime caplet - benzoic acid, carnauba wax, D&C yellow #10 lake, FD&C blue #1 lake, FD&C red #40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.
Questions or comments?
call 1-800-452-0051
Package/Label Principal Display Panel
COMTREX
MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS
acetaminophen, chlorpheniramine maleate, phenylephrin hcl kit |
|
|
|
|
|
|
| Part 1 of 2 |
COMTREX
MAXIMUM STRENGTH DAYTIME SEVERE COLD AND SINUS
acetaminophen, phenylephrin hcl tablet, film coated |
|
|
|
|
|
|
|
|
|
|
|
|
| Part 2 of 2 |
COMTREX
MAXIMUM STRENGTH NIGHTTIME SEVERE COLD AND SINUS
acetaminophen, chlorpheniramine maleate, phenylephrin hcl tablet, film coated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novartis Consumer Health, Inc.
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
