COMTREX COUGH AND COLD DAY/NIGHT- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate
Dr. Reddy's Laboratories 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 caplet) (Cold Multi-Symptom Day) | Purpose |
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Active ingredients (in each caplet) (Cold Multi-Symptom Night) | Purpose |
Acetaminophen 325 mg | Pain reliever/fever reducer |
Chlorpheniramine maleate 2 mg | Antihistamine |
Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold/flu symptoms:
- headache
- minor aches and pains
- nasal congestion
- sinus congestion and pressure
- sore throat
- cough
- sneezing and runny nose (Cold Night only)
- helps clear nasal passages
- temporarily reduces fever
- promotes nasal and sinus drainage (Cold Day only)
- relieves cough to help you sleep (Cold Night only)
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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
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.
Ask a doctor before use if you have
- diabetes
- high blood pressure
- heart disease
- thyroid disease
- liver disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- glaucoma (Cold Night only)
- a breathing problem such as emphysema or chronic bronchitis (Cold Night only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Cold Night only)
When using this product
-
do not exceed recommended dosage
- avoid alcoholic drinks (Cold Night only)
- marked drowsiness may occur (Cold Night only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Cold Night only)
- excitability may occur, especially in children (Cold Night only)
- be careful when driving a motor vehicle or operating machinery (Cold Night only)
Stop use and ask a doctor if
- fever gets worse or lasts more than 3 days
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
- redness or swelling is present
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.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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
(see overdose warning)
- 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
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients (Cold Day)
corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, sucralose, titanium dioxide, triacetin
Inactive ingredients (Cold Night)
corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
1-800-790-6417
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 55741-524-24
COMTREX®
COLD & COUGH
DAY
Acetaminophen
- ✓
-
Pain Reliever
- ✓
-
Fever Reducer
Dextromethorphan HBr
- ✓
-
Cough Suppressant
Phenylephrine HCl
- ✓
-
Nasal Decongestant
12 COATED CAPLETS
NIGHT
Acetaminophen
- ✓
-
Pain Reliever
- ✓
-
Fever Reducer
Chlorpheniramine maleate
- ✓
-
Antihistamine
Dextromethorphan HBr
- ✓
-
Cough Suppressant
Phenylephrine HCl
- ✓
-
Nasal Decongestant
12 COATED CAPLETS
Dr. Reddy's Laboratories Inc.