Drug Facts
Drug Labeling and Warnings
Drug Details [pdf]
COMTREX MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS- acetaminophen, chlorpheniramine maleate, phenylephrin hcl
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
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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Drug Facts
Active ingredient
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg*
Phenylephrine HCl 5 mg
* antihistamine in nighttime dose only
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:
- runny nose
- sneezing
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
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 |
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.
| COMTREX
MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS
acetaminophen, chlorpheniramine maleate, phenylephrin hcl kit |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
Revised: 7/2019
Document Id: 4f2db7f1-6ae8-41c1-866c-603fb10a285a
Set id: 801d3659-d0e8-4c3b-ac03-4fc0b9b211dc
Version: 2
Effective Time: 20190725
GlaxoSmithKli
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