FDA Label for Comtrex Cough And Cold Day/night

View Indications, Usage & Precautions

Comtrex Cough And Cold Day/night Product Label

The following document was submitted to the FDA by the labeler of this product Dr. Reddy's Laboratories Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Otc - Purpose

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)

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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